Trial Outcomes & Findings for EDWARDS INTUITY Valve System FOUNDATION Study (NCT NCT02338154)

Last Updated: 2019-11-22

Results Overview

Cardiopulmonary cross clamp time is the amount of time that the patient's aorta (blood vessel) is clamped by a surgical instrument used in cardiac surgery. This allows the normal blood flow to be sent to an artificial heart and lung machine to keep it at a constant temperature and oxygen level.

Recruitment status

COMPLETED

Target enrollment

516 participants

Primary outcome timeframe

At time of surgery; an average of 1 hour

Results posted on

2019-11-22

Participant Flow

516 Subjects were enrolled in this study, for which data is available.

Participant milestones

Participant milestones
Measure	EDWARDS INTUITY Aortic Valve Aortic valve replacement therapy Heart Valve Surgery: The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D
Overall Study STARTED	516
Overall Study Enrolled Cohort (Intent to Treat)	516
Overall Study INTUITY (Study Valve Cohort)	493
Overall Study COMPLETED	373
Overall Study NOT COMPLETED	143

Reasons for withdrawal

Reasons for withdrawal
Measure	EDWARDS INTUITY Aortic Valve Aortic valve replacement therapy Heart Valve Surgery: The system includes the EDWARDS INTUITY Valve System, Model 8300A and the EDWARDS INTUITY Delivery System, Model 8300D
Overall Study Death	46
Overall Study Valve Implant Failure	17
Overall Study Valve Explant	11
Overall Study Withdrawal by Subject or by Investigator	10
Overall Study Lost to Follow-up	8
Overall Study Other Reason	3
Overall Study Patients Without Exit Form	47
Overall Study Missing Exit Reason on Exit Form	1

Baseline Characteristics

The number analyzed is the number of patients with available data for the given parameter.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled Cohort n=516 Participants Subjects were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon placed the first guiding suture on the bioprosthesis.
Age, Continuous	75.5 years STANDARD_DEVIATION 6.4 • n=515 Participants • The number analyzed is the number of patients with available data for the given parameter.
Sex/Gender, Customized Female	223 Participants n=516 Participants
Sex/Gender, Customized Male	293 Participants n=516 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	218 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Ethnicity (NIH/OMB) Not Hispanic or Latino	240 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Race (NIH/OMB) Asian	1 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Race (NIH/OMB) Black or African American	0 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Race (NIH/OMB) White	456 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Race (NIH/OMB) More than one race	0 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=458 Participants • The number analyzed is the number of patients with available data for the given parameter.

PRIMARY outcome

Timeframe: At time of surgery; an average of 1 hour

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=476 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Time Spent on Cardiopulmonary Cross Clamp	—	—	59.7 minutes Standard Deviation 24.0	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of surgery; an average of 1.5 hours

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Cardiopulmonary bypass time is the amount of time that the patient's blood circulates through an artificial heart and lung machine during cardiac surgery.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=474 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Time Spent on Cardiopulmonary Bypass	—	—	85.9 minutes Standard Deviation 33.0	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of surgery; an average of 3.5 hours

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

The time from start of skin incision to end of skin closure.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=478 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Skin-to-skin Time	—	—	199.3 Minutes Standard Deviation 69.8	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: At time of surgery

Population: The outcome is reported for subjects where data is available.

Device technical success is defined as the successful delivery and deployment of the aortic trial heart valve with the subject leaving the operating room (OR) with valve in place.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=516 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Device Technical Success	—	—	493 Participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of surgical procedure through discharge from the ICU and hospital, an average of 3 days and 11 days respectively.

Population: The outcome is reported for subjects where data is available.

The average amount of time the subjects spent in the intensive care unit and the average total length of hospital stay after their heart valve replacement procedure.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=516 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Health Care Utilization Hospital Length of Stay	—	—	11.2 Days Standard Deviation 18.4	—	—	—
Subject's Average Health Care Utilization ICU Length of Stay	—	—	2.8 Days Standard Deviation 3.9	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days, 3 months, 1 year, 2 years

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

The New York Heart Association (NYHA) functional classification system relates symptoms to everyday activities and the patient's quality of life. Class I. Patients with cardiac disease but without resulting limitation of physical activity. Class II. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Class III. Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Class IV. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=493 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 30 Days · Improved	—	—	272 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 30 Days · Same	—	—	129 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 30 Days · Worsened	—	—	17 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Months · Improved	—	—	326 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Months · Same	—	—	99 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 3 Months · Worsened	—	—	8 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Improved	—	—	293 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Same	—	—	63 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 1 Year · Worsened	—	—	8 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Improved	—	—	255 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Same	—	—	80 Participants	—	—	—
Subject's New York Heart Association (NYHA) Functional Class Compared to Baseline 2 Year · Worsened	—	—	15 Participants	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 3 months

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

The EQ-5D is a standardized questionnaire that asks subjects to rate themselves (no problems, some problems, extreme problems) on mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scale is indexed and ranges from a minimum of 0.275 and a maximum of 1.000. A lower number indicates the participants experiences more problems and a higher number indicates the participants experiences fewer problems.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=493 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time Baseline	—	—	0.818 units on a scale Standard Deviation 0.137	—	—	—
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time 3 Months	—	—	0.864 units on a scale Standard Deviation 0.149	—	—	—
Subject's Average Score on the EQ-5D- Quality of Life Questionnaire Over Time Change from Baseline to 3 Months	—	—	0.040 units on a scale Standard Deviation 0.131	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, discharge, 3 months, and 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Mean gradient is the average flow of blood through the aortic valve measured in millimeters of mercury. Gradients are evaluated by echocardiography over time. Mean gradient values depend on the size and type of valve.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Mean Gradient Measurements Baseline	44.83 mmHg Standard Deviation 14.79	47.74 mmHg Standard Deviation 16.90	51.22 mmHg Standard Deviation 21.24	49.11 mmHg Standard Deviation 16.81	47.51 mmHg Standard Deviation 16.70	44.36 mmHg Standard Deviation 13.33
Subject's Average Mean Gradient Measurements Discharge	7.77 mmHg Standard Deviation 2.96	11.61 mmHg Standard Deviation 7.00	15.83 mmHg Standard Deviation 8.35	11.74 mmHg Standard Deviation 6.42	10.69 mmHg Standard Deviation 5.98	10.69 mmHg Standard Deviation 7.65
Subject's Average Mean Gradient Measurements 3 months	7.38 mmHg Standard Deviation 2.80	10.36 mmHg Standard Deviation 6.34	14.58 mmHg Standard Deviation 8.26	10.96 mmHg Standard Deviation 6.01	9.73 mmHg Standard Deviation 5.98	8.34 mmHg Standard Deviation 4.68
Subject's Average Mean Gradient Measurements 1 Year	7.25 mmHg Standard Deviation 3.13	9.64 mmHg Standard Deviation 4.60	13.16 mmHg Standard Deviation 6.90	10.14 mmHg Standard Deviation 4.28	8.96 mmHg Standard Deviation 3.72	8.45 mmHg Standard Deviation 3.03

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, discharge, 3 months, and 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Peak gradient is the maximum value measured of flow of blood through the aortic valve as measured in millimeters of mercury. Gradients are evaluated by echocardiography over time.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Peak Gradients (mmHg) Measurements Over Time Baseline	72.51 mmHg Standard Deviation 21.22	77.56 mmHg Standard Deviation 26.55	83.75 mmHg Standard Deviation 33.17	78.92 mmHg Standard Deviation 28.21	77.08 mmHg Standard Deviation 25.15	73.11 mmHg Standard Deviation 20.92
Subject's Average Peak Gradients (mmHg) Measurements Over Time Discharge	14.00 mmHg Standard Deviation 5.63	21.65 mmHg Standard Deviation 11.40	29.42 mmHg Standard Deviation 12.83	21.88 mmHg Standard Deviation 10.53	20.29 mmHg Standard Deviation 9.75	19.78 mmHg Standard Deviation 12.28
Subject's Average Peak Gradients (mmHg) Measurements Over Time 3 Months	14.00 mmHg Standard Deviation 4.96	20.18 mmHg Standard Deviation 11.32	27.46 mmHg Standard Deviation 13.64	21.12 mmHg Standard Deviation 10.32	19.48 mmHg Standard Deviation 11.90	16.52 mmHg Standard Deviation 7.82
Subject's Average Peak Gradients (mmHg) Measurements Over Time 1 Year	13.29 mmHg Standard Deviation 5.37	17.70 mmHg Standard Deviation 7.31	23.88 mmHg Standard Deviation 8.57	18.29 mmHg Standard Deviation 7.17	16.97 mmHg Standard Deviation 6.77	15.40 mmHg Standard Deviation 4.94

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, discharge, 3 months, 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

Effective orifice area represents the cross-sectional area of the blood flow downstream of the aortic valve. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Effective Orifice Area Measurements Baseline	0.81 Centimeters squared Standard Deviation 0.25	0.72 Centimeters squared Standard Deviation 0.29	0.62 Centimeters squared Standard Deviation 0.16	0.71 Centimeters squared Standard Deviation 0.29	0.75 Centimeters squared Standard Deviation 0.34	0.74 Centimeters squared Standard Deviation 0.26
Subject's Average Effective Orifice Area Measurements Discharge	2.83 Centimeters squared Standard Deviation 0.90	1.86 Centimeters squared Standard Deviation 0.73	1.17 Centimeters squared Standard Deviation 0.41	1.66 Centimeters squared Standard Deviation 0.53	2.00 Centimeters squared Standard Deviation 0.64	2.18 Centimeters squared Standard Deviation 0.70
Subject's Average Effective Orifice Area Measurements 3 Months	2.54 Centimeters squared Standard Deviation 0.77	1.77 Centimeters squared Standard Deviation 0.67	1.14 Centimeters squared Standard Deviation 0.39	1.59 Centimeters squared Standard Deviation 0.52	1.86 Centimeters squared Standard Deviation 0.62	2.10 Centimeters squared Standard Deviation 0.59
Subject's Average Effective Orifice Area Measurements 1 Year	2.64 Centimeters squared Standard Deviation 0.73	1.88 Centimeters squared Standard Deviation 0.63	1.28 Centimeters squared Standard Deviation 0.33	1.61 Centimeters squared Standard Deviation 0.43	1.97 Centimeters squared Standard Deviation 0.42	2.23 Centimeters squared Standard Deviation 0.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 months, 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

Effective orifice area index represents the minimal cross-sectional area of the blood flow downstream of the aortic valve divided by the person's body surface area. Effective orifice area index is evaluated by echocardiography over time.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Effective Orifice Area Index (EOAI) Measurements Baseline	0.40 centimeters squared/meters squared Standard Deviation 0.12	0.39 centimeters squared/meters squared Standard Deviation 0.16	0.37 centimeters squared/meters squared Standard Deviation 0.10	0.41 centimeters squared/meters squared Standard Deviation 0.18	0.40 centimeters squared/meters squared Standard Deviation 0.17	0.37 centimeters squared/meters squared Standard Deviation 0.14
Subject's Average Effective Orifice Area Index (EOAI) Measurements 3 Months	1.23 centimeters squared/meters squared Standard Deviation 0.42	0.96 centimeters squared/meters squared Standard Deviation 0.37	0.69 centimeters squared/meters squared Standard Deviation 0.24	0.91 centimeters squared/meters squared Standard Deviation 0.31	0.99 centimeters squared/meters squared Standard Deviation 0.40	1.09 centimeters squared/meters squared Standard Deviation 0.34
Subject's Average Effective Orifice Area Index (EOAI) Measurements Discharge	1.40 centimeters squared/meters squared Standard Deviation 0.50	0.99 centimeters squared/meters squared Standard Deviation 0.38	0.69 centimeters squared/meters squared Standard Deviation 0.26	0.92 centimeters squared/meters squared Standard Deviation 0.31	1.05 centimeters squared/meters squared Standard Deviation 0.34	1.15 centimeters squared/meters squared Standard Deviation 0.35
Subject's Average Effective Orifice Area Index (EOAI) Measurements 1 Year	1.30 centimeters squared/meters squared Standard Deviation 0.48	1.01 centimeters squared/meters squared Standard Deviation 0.31	0.76 centimeters squared/meters squared Standard Deviation 0.21	0.92 centimeters squared/meters squared Standard Deviation 0.26	1.06 centimeters squared/meters squared Standard Deviation 0.22	1.13 centimeters squared/meters squared Standard Deviation 0.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 Months, 1 Year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

Performance index is defined as the subject's effective orifice area (the cross-sectional area of the blood flow downstream of the aortic valve) divided by the subject's native orifice area. Effective orifice area is evaluated by echocardiography over time.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Performance Index Measurements 1 Year	0.58 cm^2/cm^2 Standard Deviation 0.13	0.53 cm^2/cm^2 Standard Deviation 0.13	0.48 cm^2/cm^2 Standard Deviation 0.12	0.51 cm^2/cm^2 Standard Deviation 0.14	0.55 cm^2/cm^2 Standard Deviation 0.12	0.53 cm^2/cm^2 Standard Deviation 0.13
Subject's Average Performance Index Measurements Discharge	0.56 cm^2/cm^2 Standard Deviation 0.12	0.50 cm^2/cm^2 Standard Deviation 0.13	0.44 cm^2/cm^2 Standard Deviation 0.12	0.49 cm^2/cm^2 Standard Deviation 0.13	0.53 cm^2/cm^2 Standard Deviation 0.14	0.49 cm^2/cm^2 Standard Deviation 0.12
Subject's Average Performance Index Measurements 3 Months	0.57 cm^2/cm^2 Standard Deviation 0.13	0.52 cm^2/cm^2 Standard Deviation 0.13	0.44 cm^2/cm^2 Standard Deviation 0.12	0.50 cm^2/cm^2 Standard Deviation 0.12	0.55 cm^2/cm^2 Standard Deviation 0.13	0.52 cm^2/cm^2 Standard Deviation 0.13

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, discharge, 3 months, 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Ejection fraction is a measurement of the percentage of blood leaving your heart each time it contracts. Ejection fraction is evaluated by echocardiography over time. A normal left ventricular ejection fraction (LVEF) ranges from 55% to 70%.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Left Ventricular Ejection Fraction (LVEF) Baseline	62.96 Percentage of blood Standard Deviation 9.29	64.37 Percentage of blood Standard Deviation 11.75	66.71 Percentage of blood Standard Deviation 9.85	65.87 Percentage of blood Standard Deviation 11.89	64.56 Percentage of blood Standard Deviation 11.73	60.57 Percentage of blood Standard Deviation 12.85
Subject's Average Left Ventricular Ejection Fraction (LVEF) 1 Year	63.64 Percentage of blood Standard Deviation 9.35	64.23 Percentage of blood Standard Deviation 8.41	64.28 Percentage of blood Standard Deviation 8.12	64.64 Percentage of blood Standard Deviation 8.23	64.65 Percentage of blood Standard Deviation 8.98	63.30 Percentage of blood Standard Deviation 7.75
Subject's Average Left Ventricular Ejection Fraction (LVEF) Discharge	61.12 Percentage of blood Standard Deviation 13.36	64.16 Percentage of blood Standard Deviation 11.73	66.05 Percentage of blood Standard Deviation 11.40	64.16 Percentage of blood Standard Deviation 11.63	65.87 Percentage of blood Standard Deviation 10.70	60.45 Percentage of blood Standard Deviation 12.57
Subject's Average Left Ventricular Ejection Fraction (LVEF) 3 Months	63.08 Percentage of blood Standard Deviation 10.24	64.67 Percentage of blood Standard Deviation 9.79	64.58 Percentage of blood Standard Deviation 6.96	66.26 Percentage of blood Standard Deviation 9.88	65.20 Percentage of blood Standard Deviation 9.51	62.36 Percentage of blood Standard Deviation 11.29

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Aortic valvular regurgitation occurs when the aortic valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Aortic valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · 0 None	19 Participants	260 Participants	34 Participants	69 Participants	83 Participants	52 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 1 Year · +4 Severe	0 Participants	2 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +1 Trivial/Trace	6 Participants	140 Participants	29 Participants	39 Participants	42 Participants	22 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +2 Mild	1 Participants	28 Participants	5 Participants	9 Participants	9 Participants	4 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +3 Moderate	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. Discharge · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 3 Months · 0 None	21 Participants	249 Participants	25 Participants	67 Participants	80 Participants	55 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 3 Months · +1 Trivial/Trace	8 Participants	144 Participants	28 Participants	39 Participants	43 Participants	24 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 3 Months · +2 Mild	1 Participants	28 Participants	7 Participants	7 Participants	9 Participants	4 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 3 Months · +3 Moderate	0 Participants	8 Participants	1 Participants	2 Participants	5 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 3 Months · +4 Severe	0 Participants	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 1 Year · 0 None	18 Participants	236 Participants	29 Participants	60 Participants	78 Participants	49 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 1 Year · +1 Trivial/Trace	9 Participants	85 Participants	15 Participants	23 Participants	21 Participants	17 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 1 Year · +2 Mild	1 Participants	30 Participants	5 Participants	9 Participants	12 Participants	3 Participants
Subject's Amount of Aortic Valvular Regurgitation Over Time. 1 Year · +3 Moderate	0 Participants	5 Participants	1 Participants	1 Participants	3 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Paravalvular leak refers to blood flowing through a channel between the implanted artificial valve and the cardiac tissue as a result of inappropriate sealing. Paravalvular leak is evaluated by echocardiography over time. It is assessed on a scale from minimum of 0 to maximum of 4, where 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak. Higher numbers on the scale show a worsening outcome.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Amount of Paravalvular Leak Over Time. 3 Months · +2 Mild	1 Participants	26 Participants	3 Participants	6 Participants	12 Participants	4 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · 0 None	22 Participants	358 Participants	59 Participants	99 Participants	105 Participants	69 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +1 Trivial/Trace	1 Participants	55 Participants	4 Participants	18 Participants	25 Participants	6 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +2 Mild	1 Participants	16 Participants	4 Participants	1 Participants	6 Participants	4 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +3 Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time. Discharge · +4 Severe	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time. 3 Months · 0 None	22 Participants	324 Participants	52 Participants	84 Participants	96 Participants	67 Participants
Subject's Amount of Paravalvular Leak Over Time. 3 Months · +1 Trivial/Trace	5 Participants	63 Participants	5 Participants	20 Participants	22 Participants	11 Participants
Subject's Amount of Paravalvular Leak Over Time. 3 Months · +3 Moderate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time. 3 Months · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time. 1 Year · 0 None	20 Participants	238 Participants	32 Participants	64 Participants	65 Participants	56 Participants
Subject's Amount of Paravalvular Leak Over Time. 1 Year · +1 Trivial/Trace	4 Participants	53 Participants	9 Participants	17 Participants	16 Participants	6 Participants
Subject's Amount of Paravalvular Leak Over Time. 1 Year · +2 Mild	0 Participants	20 Participants	1 Participants	2 Participants	14 Participants	3 Participants
Subject's Amount of Paravalvular Leak Over Time. 1 Year · +3 Moderate	0 Participants	2 Participants	1 Participants	0 Participants	1 Participants	0 Participants
Subject's Amount of Paravalvular Leak Over Time. 1 Year · +4 Severe	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 months, 1 year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

The amount of blood the heart pumps through the circulatory system in a minute.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Cardiac Output Over Time Discharge	5.09 liters per minute Standard Deviation 1.82	4.49 liters per minute Standard Deviation 1.42	4.14 liters per minute Standard Deviation 1.39	4.24 liters per minute Standard Deviation 1.31	4.60 liters per minute Standard Deviation 1.33	4.74 liters per minute Standard Deviation 1.48
Subject's Average Cardiac Output Over Time 3 Months	5.08 liters per minute Standard Deviation 1.57	4.26 liters per minute Standard Deviation 1.23	3.85 liters per minute Standard Deviation 1.40	4.36 liters per minute Standard Deviation 1.15	4.29 liters per minute Standard Deviation 1.12	4.16 liters per minute Standard Deviation 1.19
Subject's Average Cardiac Output Over Time 1 Year	5.90 liters per minute Standard Deviation 1.76	4.50 liters per minute Standard Deviation 1.37	3.86 liters per minute Standard Deviation 1.28	4.26 liters per minute Standard Deviation 1.11	4.61 liters per minute Standard Deviation 1.30	4.61 liters per minute Standard Deviation 1.30

OTHER_PRE_SPECIFIED outcome

Timeframe: Discharge, 3 Months, 1 Year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

A hemodynamic parameter that relates the cardiac output (CO) from left ventricle in one minute to body surface area (BSA).

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Cardiac Output Index Discharge	2.45 L/min/m2 Standard Deviation 0.77	2.45 L/min/m2 Standard Deviation 0.78	2.45 L/min/m2 Standard Deviation 0.89	2.40 L/min/m2 Standard Deviation 0.79	2.44 L/min/m2 Standard Deviation 0.75	2.54 L/min/m2 Standard Deviation 0.72
Subject's Average Cardiac Output Index 3 Months	2.61 L/min/m2 Standard Deviation 1.00	2.40 L/min/m2 Standard Deviation 0.72	2.40 L/min/m2 Standard Deviation 0.88	2.54 L/min/m2 Standard Deviation 0.67	2.33 L/min/m2 Standard Deviation 0.62	2.21 L/min/m2 Standard Deviation 0.65
Subject's Average Cardiac Output Index 1 Year	2.88 L/min/m2 Standard Deviation 1.09	2.45 L/min/m2 Standard Deviation 0.74	2.32 L/min/m2 Standard Deviation 0.81	2.47 L/min/m2 Standard Deviation 0.68	2.49 L/min/m2 Standard Deviation 0.71	2.32 L/min/m2 Standard Deviation 0.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

The measurement of the heart's left ventricle at end diastole.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Left Ventricular End-Diastolic Dimension Baseline	4.92 centimeters Standard Deviation 0.67	4.41 centimeters Standard Deviation 0.72	4.05 centimeters Standard Deviation 0.58	4.30 centimeters Standard Deviation 0.74	4.38 centimeters Standard Deviation 0.63	4.76 centimeters Standard Deviation 0.72
Subject's Average Left Ventricular End-Diastolic Dimension Discharge	4.67 centimeters Standard Deviation 1.30	4.27 centimeters Standard Deviation 0.76	3.92 centimeters Standard Deviation 0.67	4.09 centimeters Standard Deviation 0.68	4.35 centimeters Standard Deviation 0.65	4.51 centimeters Standard Deviation 0.73
Subject's Average Left Ventricular End-Diastolic Dimension 3 Months	4.88 centimeters Standard Deviation 0.79	4.29 centimeters Standard Deviation 0.67	3.93 centimeters Standard Deviation 0.59	4.17 centimeters Standard Deviation 0.59	4.25 centimeters Standard Deviation 0.62	4.55 centimeters Standard Deviation 0.68
Subject's Average Left Ventricular End-Diastolic Dimension 1 Year	4.72 centimeters Standard Deviation 0.64	4.30 centimeters Standard Deviation 0.68	3.98 centimeters Standard Deviation 0.64	4.08 centimeters Standard Deviation 0.71	4.43 centimeters Standard Deviation 0.54	4.47 centimeters Standard Deviation 0.72

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

The measurement of the heart's left ventricle at end systole.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Subject's Average Left Ventricular End-Systolic Dimension 1 Year	3.06 centimeters Standard Deviation 0.68	2.82 centimeters Standard Deviation 0.64	2.63 centimeters Standard Deviation 0.61	2.69 centimeters Standard Deviation 0.69	2.90 centimeters Standard Deviation 0.54	2.91 centimeters Standard Deviation 0.68
Subject's Average Left Ventricular End-Systolic Dimension Baseline	3.36 centimeters Standard Deviation 0.82	2.96 centimeters Standard Deviation 0.79	2.63 centimeters Standard Deviation 0.60	2.80 centimeters Standard Deviation 0.75	2.99 centimeters Standard Deviation 0.72	3.29 centimeters Standard Deviation 0.91
Subject's Average Left Ventricular End-Systolic Dimension Discharge	3.32 centimeters Standard Deviation 0.84	2.92 centimeters Standard Deviation 0.72	2.60 centimeters Standard Deviation 0.65	2.80 centimeters Standard Deviation 0.73	2.97 centimeters Standard Deviation 0.69	3.07 centimeters Standard Deviation 0.70
Subject's Average Left Ventricular End-Systolic Dimension 3 Months	3.31 centimeters Standard Deviation 0.75	2.82 centimeters Standard Deviation 0.64	2.53 centimeters Standard Deviation 0.56	2.70 centimeters Standard Deviation 0.62	2.81 centimeters Standard Deviation 0.56	3.02 centimeters Standard Deviation 0.67

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

Left Ventricular end-diastolic volume (LVEDV) is the amount of (volume) of blood in the left ventricle at end load or filling in (diastole) or the amount of blood in the ventricle just before systole.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Left Ventricular End-diastolic Volume (LVEDV) Baseline	109.90 milliliters Standard Deviation 41.78	83.00 milliliters Standard Deviation 33.22	62.68 milliliters Standard Deviation 23.55	75.17 milliliters Standard Deviation 27.76	83.52 milliliters Standard Deviation 31.17	101.91 milliliters Standard Deviation 33.55
Left Ventricular End-diastolic Volume (LVEDV) Discharge	102.27 milliliters Standard Deviation 39.83	69.74 milliliters Standard Deviation 28.83	52.90 milliliters Standard Deviation 20.35	63.26 milliliters Standard Deviation 24.58	70.93 milliliters Standard Deviation 24.61	82.10 milliliters Standard Deviation 30.54
Left Ventricular End-diastolic Volume (LVEDV) 3 Months	93.42 milliliters Standard Deviation 31.21	74.78 milliliters Standard Deviation 28.67	56.96 milliliters Standard Deviation 24.76	64.89 milliliters Standard Deviation 20.44	74.94 milliliters Standard Deviation 23.96	91.66 milliliters Standard Deviation 32.80
Left Ventricular End-diastolic Volume (LVEDV) 1 Year	86.47 milliliters Standard Deviation 31.99	76.69 milliliters Standard Deviation 26.49	60.86 milliliters Standard Deviation 21.22	72.46 milliliters Standard Deviation 22.17	79.12 milliliters Standard Deviation 26.37	85.80 milliliters Standard Deviation 27.47

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, Discharge, 3 Months, 1 Year

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY valve where data is available.

Left Ventricular end-systolic volume (LVESV) is the amount of (volume) of blood in the left ventricle at the end of the heart's contraction, or systole, and the beginning of filling, or diastole.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm n=30 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall n=486 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=73 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm n=134 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm n=157 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm n=92 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.
Left Ventricular End-systolic Volume (LVESV) Baseline	40.76 milliliters Standard Error 24.75	31.22 milliliters Standard Error 21.41	22 milliliters Standard Error 13.47	27.50 milliliters Standard Error 18.97	30.46 milliliters Standard Error 19.03	42.36 milliliters Standard Error 26.74
Left Ventricular End-systolic Volume (LVESV) Discharge	41.36 milliliters Standard Error 27.97	25.99 milliliters Standard Error 17.46	18.57 milliliters Standard Error 12.38	23.90 milliliters Standard Error 15.69	24.51 milliliters Standard Error 13.95	33.27 milliliters Standard Error 19.96
Left Ventricular End-systolic Volume (LVESV) 3 Months	35.50 milliliters Standard Error 19.66	27.07 milliliters Standard Error 17.36	20.10 milliliters Standard Error 10.93	22.33 milliliters Standard Error 13.05	26.17 milliliters Standard Error 14.66	35.77 milliliters Standard Error 22.99
Left Ventricular End-systolic Volume (LVESV) 1 Year	31.68 milliliters Standard Error 19.08	27.98 milliliters Standard Error 13.64	21.86 milliliters Standard Error 9.28	26.62 milliliters Standard Error 12.57	28.37 milliliters Standard Error 14.15	32.00 milliliters Standard Error 13.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Events occurring within 30 days of procedure

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Number of Subjects with early adverse events occurring within 30 days of procedure divided by the number of enrolled subjects times 100.

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=493 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Percentage of Subjects With Early Adverse Events All cause mortality	—	—	3.0 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Study valve-related mortality	—	—	1.4 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Thromboembolic events	—	—	3.9 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Study valve thrombosis	—	—	0.2 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Bleeding event	—	—	6.3 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events All paravalvular leak	—	—	15.0 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Major paravalvular leak (Moderate or Severe)	—	—	1.2 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Endocarditis	—	—	0.0 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Structural valve deterioration	—	—	0.0 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Non-structural valve deterioration (other than PVL	—	—	0.0 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Hemolysis	—	—	0.4 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Reoperation	—	—	1.2 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events Explant	—	—	0.8 Percentage of subjects	—	—	—
Percentage of Subjects With Early Adverse Events New and worsening conduction disturbance	—	—	7.3 Percentage of subjects	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Events occurring >= 31 days and up through 2 years post-implant

Population: This outcome is reported for subjects who received a Model 8300A Edwards INTUITY Valve where data is available.

Number of late events divided by the total number of late patient years times 100. Late patient years are calculated from 31 days post-implant to the date of the last contact (follow up or adverse event).

Outcome measures

Outcome measures
Measure	INTUITY (Study Valve Cohort) - 27mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - Overall The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) n=493 Participants The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 21mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 23mm The study valve cohort consists of all patients that left the operating room with the study valve in place.	INTUITY (Study Valve Cohort) - 25mm The study valve cohort consists of all patients that left the operating room with the study valve in place.
Percentage of Late Adverse Events Divided by Late Patient Years All cause mortality	—	—	3.6 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Study valve-related mortality	—	—	1.4 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Thromboembolic events	—	—	1.6 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Study valve thrombosis	—	—	0.0 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Bleeding event	—	—	0.6 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years All Paravalvular Leak	—	—	10.8 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Major paravalvular leak (Moderate or Severe)	—	—	1.3 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Endocarditis	—	—	0.6 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Structural valve deterioration	—	—	0.0 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Non-structural valve deterioration (other than PVL	—	—	0.0 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Hemolysis	—	—	0.4 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Reoperation	—	—	1.1 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years Explant	—	—	0.7 Percentage of events/late patient years	—	—	—
Percentage of Late Adverse Events Divided by Late Patient Years New and worsening conduction disturbance	—	—	0.0 Percentage of events/late patient years	—	—	—

Adverse Events

Enrolled Cohort

Serious events: 245 serious events

Other events: 157 other events

Deaths: 46 deaths

Serious adverse events

Serious adverse events
Measure	Enrolled Cohort n=516 participants at risk Subject's were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon places the first guiding suture on the bioprosthesis.
General disorders Anaphylactic Reaction	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Anemia - Bleeding related - Major	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Anemia - Bleeding related - Minor	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Anemia - Non-bleeding related	1.9% 10/516 • Number of events 13 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Angina, Stable	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Angina, Unstable	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - AV Block - 1st degree	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - AV Block - 2nd degree	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - AV Block - 3rd degree	4.8% 25/516 • Number of events 25 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Atrial Flutter	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Bradycardia	0.78% 4/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Bundle Branch Block - Left	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Other	0.97% 5/516 • Number of events 5 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	6.6% 34/516 • Number of events 39 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Permanent Atrial Fibrillation	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Persistant Atrial Fibrillaiton	1.7% 9/516 • Number of events 12 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Tachycardia - Ventricular	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Ventricular Fibrillation	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Gastrointestinal disorders Biliary (Gallbladder)	0.97% 5/516 • Number of events 6 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Major	3.1% 16/516 • Number of events 18 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Minor	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Gastrointestinal upper -Major	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Gastrointestinal upper -Minor	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Neurological - Major (e.g. CVA)	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Pulmonary/Respiratory - Major (e.g. hemothorax)	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Blood Sepsis	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Blood/ Lymphatic - Other	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Musculoskeletal and connective tissue disorders Bone Fracture/Break	1.6% 8/516 • Number of events 8 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Cancer - Newly diagnosed	1.7% 9/516 • Number of events 9 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Cancer - Progression of underlying disease	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Cardiac Arrest	0.78% 4/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Cardiac Decompensation	1.6% 8/516 • Number of events 8 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Cardiogenic Shock	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Cardiovascular - Other	2.7% 14/516 • Number of events 14 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Endocarditis	0.97% 5/516 • Number of events 5 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Gastrointestinal disorders Gastrointestinal - Infection	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Gastrointestinal disorders Gastrointestinal - Other	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Genitourinary - Other	1.4% 7/516 • Number of events 7 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Heart Failure - Acute	1.7% 9/516 • Number of events 11 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Heart Failure - Chronic (CHF)	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Hepatobiliary disorders Hepatic complication - Other	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Hypertension - Systemic	0.78% 4/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Hypotension	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Infections and infestations Infection /Inflammation - Other	0.97% 5/516 • Number of events 6 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Hepatobiliary disorders Liver Failure - Acute	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Multi-System organ failure	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Musculoskeletal and connective tissue disorders Muscular Skeletal / Dermatologic - Other	3.3% 17/516 • Number of events 18 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Myocardial Infarction	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders NSD - Paravalvular Leak - +2	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders NSD - Paravalvular Leak - +3	0.58% 3/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders NSD - Paravalvular Leak - +4	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Nonspecific, Unknown, or Other Body System - Other complication	3.3% 17/516 • Number of events 18 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Gastrointestinal disorders Pancreatic complication	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Perforation - Atrial	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Perforation - Other	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Pericardial Effusion - Major	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Pericardial Effusion - Minor	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Pericardial Tamponade - Major	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Pleural Effusion - Bilateral	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Pleural Effusion - Left	0.78% 4/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Pleural Effusion - Right	1.4% 7/516 • Number of events 7 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Psychiatric disorders Psychiatric - Other	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Psychiatric disorders Psychiatric Disorder	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pulmonary Edema	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism - Bilateral	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism - Right	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory - Other	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Regurgitation - Aortic-Central/Transvalvular-+3	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Regurgitation - Aortic-Central/Transvalvular-+4	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Regurgitation - Aortic-Indeterminate-+2	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Regurgitation - Aortic-Indeterminate-+4	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Renal Dysfunction	1.7% 9/516 • Number of events 9 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Renal Failure - Acute	2.3% 12/516 • Number of events 12 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Renal Failure - Chronic	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Dysfunction/Insufficiency	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Failure -COPD	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Failure -Other	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Failure -Pneumonia	1.2% 6/516 • Number of events 6 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Failure -Pneumothorax	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Pneumonia	1.9% 10/516 • Number of events 10 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Upper (URI)	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Product Issues SVD - Stent frame separation	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Speech disorder	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Musculoskeletal and connective tissue disorders Sternal Wound/Thoracic Infection	1.6% 8/516 • Number of events 10 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Psychiatric disorders Suicide	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Thromboembolic Event - Other - Central - Hemiparesis	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Thromboembolic Event - Other - Peripheral - No paresis	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Thromboembolic Event - Stroke	1.9% 10/516 • Number of events 11 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Thromboembolic Event - Transient Ischemic Attack (TIA)	0.78% 4/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Urinary Tract Infection (UTI)	0.58% 3/516 • Number of events 5 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Valve Thrombosis - Aortic	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Vascular disorders Vascular - Other	1.6% 8/516 • Number of events 9 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders NSD - Paravalvular leak with Hemolysis	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Failure -Acute Respiratory Distress Syndrome (ARDS)	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.

Other adverse events

Other adverse events
Measure	Enrolled Cohort n=516 participants at risk Subject's were considered enrolled into the clinical study when he/she signed the informed consent, met all the study eligibility criteria, and after the surgeon places the first guiding suture on the bioprosthesis.
Psychiatric disorders Psychiatric - Other	1.2% 6/516 • Number of events 6 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Psychiatric disorders Psychiatric Disorder	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Allergic Reaction - Medication related	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Anemia - Bleeding related - Major	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Anemia - Bleeding related - Minor	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Anemia - Non-bleeding related	2.3% 12/516 • Number of events 13 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Angina, Stable	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - AV Block - 1st degree	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - AV Block - 3rd degree	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Bundle Branch Block - Left	2.3% 12/516 • Number of events 12 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Bundle Branch Block - Right	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Paroxysmal Atrial Fibrillation (PAF)	8.9% 46/516 • Number of events 47 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Permanent Atrial Fibrillation	0.78% 4/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Persistant Atrial Fibrillaiton	2.9% 15/516 • Number of events 15 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Arrhythmia - Tachycardia - Ventricular	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Gastrointestinal disorders Biliary (Gallbladder)	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Cardiovascular - Minor	0.97% 5/516 • Number of events 5 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Gastrointestinal lower -Minor	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Gastrointestinal upper -Minor	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Genitourinary - Minor	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Bleeding - Peripheral vascular - Minor (e.g. nosebleeds; hematomas)	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Blood/ Lymphatic - Other	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Musculoskeletal and connective tissue disorders Bone Fracture/Break	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Cancer - Newly diagnosed	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Cardiovascular - Other	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Endocrine disorders Endocrine complications	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Gastrointestinal disorders Gastrointestinal - Other	1.4% 7/516 • Number of events 7 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Heart Failure - Chronic (CHF)	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Hepatobiliary disorders Hepatic complication - Other	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Hypertension - Systemic	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Infections and infestations Infection /Inflammation - Other	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Musculoskeletal and connective tissue disorders Muscular Skeletal / Dermatologic - Other	2.7% 14/516 • Number of events 15 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders NSD - Paravalvular Leak - +2	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders NSD - Paravalvular leak with Hemolysis	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
General disorders Nonspecific, Unknown, or Other Body System - Other complication	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Pericardial Effusion - Minor	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pleural Effusion - Bilateral	1.2% 6/516 • Number of events 6 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pleural Effusion - Left	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Pulmonary/Respiratory - Other	0.97% 5/516 • Number of events 5 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Renal Dysfunction	1.2% 6/516 • Number of events 6 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Renal Failure - Acute	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Dysfunction/Insufficiency	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Failure -COPD	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Pneumonia	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Respiratory, thoracic and mediastinal disorders Respiratory Infection - Upper (URI)	0.78% 4/516 • Number of events 4 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Musculoskeletal and connective tissue disorders Sternal Wound/Thoracic Infection	0.39% 2/516 • Number of events 2 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Blood and lymphatic system disorders Thrombocytopenia - Non-Heparin Induced	0.97% 5/516 • Number of events 5 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Thromboembolic Event - Other - Peripheral - Hemiparesis	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Thromboembolic Event - Stroke	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Cardiac disorders Thromboembolic Event - Transient Ischemic Attack (TIA)	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Psychiatric disorders Transient Psychotic Syndrome	0.97% 5/516 • Number of events 5 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Renal and urinary disorders Urinary Tract Infection (UTI)	2.9% 15/516 • Number of events 15 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Vascular disorders Vascular - Deep Vein Thrombosis (DVT)	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Vascular disorders Vascular - Other	0.19% 1/516 • Number of events 1 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Eye disorders Vision disorder	0.58% 3/516 • Number of events 3 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.
Infections and infestations Wound Infection - Other	1.2% 6/516 • Number of events 6 • Events occurring from baseline through two (2) years post implant Adverse event table is reported using Enrolled Cohort. Where an adverse event term below includes the word "Other", those adverse events were unable to be classified into a more specific adverse event category.

Additional Information

Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart

Edwards Lifesciences, LLC

Phone: 949-250-2500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of overall study results which have not been released requires written approval of Sponsor, but presentation of site-specific results can occur subject to review by Sponsor. Manuscripts will be submitted to Sponsor for review 30 days prior to submission of manuscript for publication/presentation. Sponsor may ask for a 60 day delay of submission of manuscripts for publication to protect proprietary information and filing of related patent applications.
Publication restrictions are in place

Restriction type: OTHER