Trial Outcomes & Findings for PERIGON Japan Trial (NCT NCT02686814)
NCT ID: NCT02686814
Last Updated: 2024-04-12
Results Overview
Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
This outcome will be identified from measurement at baseline and 1 year.
Results posted on
2024-04-12
Participant Flow
Participant milestones
| Measure |
MDT-2215
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
MDT-2215
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Overall Study
Physician Decision
|
14
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
1
|
Baseline Characteristics
Baseline characteristics were summarized only on those implanted.
Baseline characteristics by cohort
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
|
Age, Continuous
|
77.7 years
STANDARD_DEVIATION 5.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
Region of Enrollment
Japan
|
11 participants
n=99 Participants
|
|
New York Heart Association (NYHA) Classification
Class I
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
New York Heart Association (NYHA) Classification
Class II
|
11 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
New York Heart Association (NYHA) Classification
Class III
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
|
New York Heart Association (NYHA) Classification
Class IV
|
0 Participants
n=99 Participants • Baseline characteristics were summarized only on those implanted.
|
PRIMARY outcome
Timeframe: This outcome will be identified from measurement at baseline and 1 year.Change in New York Heart Association (NYHA) functional classification from baseline to 1 year post-procedure will be evaluated. Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure
No Change
|
1 Participants
|
|
Number of Participants With Changes in NYHA Classification From Baseline to 1 Year Post-procedure
Improved 1 Class
|
10 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured at 1 year.Effective Orifice Area Index (EOAI) at 1 year post-procedure will be evaluated. Effective Orifice Area Index (EOAI) in cm\^2/m\^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm\^2, and BSA is the body surface area in m\^2
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Effective Orifice Area Index at Baseline and 1 Year Post-procedure
Baseline
|
0.44 cm^2/m^2
Standard Deviation 0.14
|
|
Effective Orifice Area Index at Baseline and 1 Year Post-procedure
1 Year
|
0.82 cm^2/m^2
Standard Deviation 0.17
|
PRIMARY outcome
Timeframe: This outcome will be identified from measurement at baseline and 1 year.Composite number of participants with NYHA change from baseline to 1 year post-procedure of 1 or greater and effective number of participants with effective EOAI 0.6cm\^2/m\^2 or greater at 1 year post implant will be evaluated. The objective is met if at least 60% of the subjects achieve the specified improvement in NYHA and EOAI. See Objective 1 for NYHA definition See Objective 2 for EOAI definition
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Number of Participants With Composite New York Heart Association (NYHA) Classification and Effective Orifice EOAI Endpoint Improvement From Baseline to 1 Year
|
9 Participants
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subjects excited prior to visit. Year 2: 1 subject (death) Year 4: 1 subject (withdraw/other) Year 5: 3 subjects (withdraw/other)
NYHA functional classification evaluation at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years. Measure Description: Cardiac Disease with Functional Classes I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Baseline · NYHA Classification I
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Baseline · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Baseline · Not done
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Discharge up to 30 days · Not done
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3-6 Months · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
1 Year · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
1 Year · Not done
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
2 Year · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
4 Year · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
5 Year · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Baseline · NYHA Classification II
|
11 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Baseline · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Baseline · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Discharge up to 30 days · NYHA Classification I
|
11 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Discharge up to 30 days · NYHA Classification II
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Discharge up to 30 days · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Discharge up to 30 days · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
Discharge up to 30 days · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3-6 Months · NYHA Classification I
|
10 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3-6 Months · NYHA Classification II
|
1 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3-6 Months · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3-6 Months · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3-6 Months · Not done
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
1 Year · NYHA Classification I
|
10 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
1 Year · NYHA Classification II
|
1 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
1 Year · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
1 Year · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
2 Year · NYHA Classification I
|
7 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
2 Year · NYHA Classification II
|
3 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
2 Year · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
2 Year · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
2 Year · Not done
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3 Year · NYHA Classification I
|
8 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3 Year · NYHA Classification II
|
2 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3 Year · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3 Year · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3 Year · NYHA Classification V
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
3 Year · Not done
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
4 Year · NYHA Classification I
|
6 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
4 Year · NYHA Classification II
|
2 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
4 Year · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
4 Year · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
4 Year · Not done
|
1 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
5 Year · NYHA Classification I
|
6 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
5 Year · NYHA Classification II
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
5 Year · NYHA Classification III
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
5 Year · NYHA Classification IV
|
0 Participants
|
|
Assessment of NYHA Functional Classification for Participants From Baseline up to 5 Years
5 Year · Not done
|
0 Participants
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
Effective orifice area index at baseline, discharge up to 30 days, 3-6 months, 1 year and annually thereafter through 5 years as measured by effective orifice area (cm\^2) per unit body surface area (m\^2). The achievement criterion for the effective orifice area index (EOAI) is defined to be ≥0.6 cm\^2/m\^2. Effective Orifice Area Index (EOAI) in cm\^2/m\^2 EOAI = EOA/BSA Where: EOA is the effective orifice area in cm\^2, and BSA is the body surface area in m\^2
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
Baseline
|
0.44 cm^2/m^2
Standard Deviation 0.14
|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
Discharge up to 30 days
|
0.82 cm^2/m^2
Standard Deviation 0.16
|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
3-6 Month
|
0.77 cm^2/m^2
Standard Deviation 0.18
|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
1 Year
|
0.82 cm^2/m^2
Standard Deviation 0.17
|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
2 Year
|
0.70 cm^2/m^2
Standard Deviation 0.16
|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
3 Year
|
0.78 cm^2/m^2
Standard Deviation 0.16
|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
4 Year
|
0.76 cm^2/m^2
Standard Deviation 0.13
|
|
Mean Effective Orifice Area Index (cm^2/m^2) From Baseline up to 5 Years
5 Year
|
0.66 cm^2/m^2
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
Baseline
|
0.58 cm^2
Standard Deviation 0.19
|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
Discharge up to 30 Days
|
1.08 cm^2
Standard Deviation 0.19
|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
3-6 Month
|
1.03 cm^2
Standard Deviation 0.29
|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
1 Year
|
1.10 cm^2
Standard Deviation 0.22
|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
2 Year
|
0.96 cm^2
Standard Deviation 0.21
|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
3 Year
|
1.05 cm^2
Standard Deviation 0.23
|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
4 Year
|
1.04 cm^2
Standard Deviation 0.19
|
|
Effective Orifice Area (cm^2) From Baseline up to 5 Years
5 Year
|
0.90 cm^2
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
Basline
|
85.3 mmHg
Standard Deviation 29.7
|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
Discharge up to 30 Days
|
33.5 mmHg
Standard Deviation 11.0
|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
3-6 Month
|
36.5 mmHg
Standard Deviation 9.6
|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
1 Year
|
34.7 mmHg
Standard Deviation 12.7
|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
2 Year
|
35.6 mmHg
Standard Deviation 11.4
|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
3 Year
|
32.5 mmHg
Standard Deviation 11.1
|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
4 Year
|
33.4 mmHg
Standard Deviation 12.2
|
|
Peak Pressure Gradient (mmHg) From Discharge up to 5 Years
5 Year
|
41.8 mmHg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
Baseline
|
53.3 mmHg
Standard Deviation 17.7
|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
Discharge up to 30 Days
|
18.5 mmHg
Standard Deviation 5.2
|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
3-6 Month
|
20.6 mmHg
Standard Deviation 5.8
|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
1 Year
|
20.9 mmHg
Standard Deviation 8.2
|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
2 Year
|
20.3 mmHg
Standard Deviation 5.7
|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
3 Year
|
18.8 mmHg
Standard Deviation 6.4
|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
4 Year
|
18.5 mmHg
Standard Deviation 6.5
|
|
Mean Pressure Gradient (mmHg) From Discharge up to 5 Years
5 Year
|
24.2 mmHg
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
1 Year · Mild
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
2 Year · Not Evaluable
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3 Year · None
|
9 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
4 Year · None
|
6 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
4 Year · Trace
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
5 Year · Not Acquired
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Not Evaluable
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3-6 Months · None
|
9 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Trace
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Mild
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Moderate
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · None
|
8 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Trace
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Mild
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Moderate
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Severe
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Not Acquired
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Severe
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Not Acquired
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Not Evaluable
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
1 Year · None
|
10 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
1 Year · Trace
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
1 Year · Moderate
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
1 Year · Severe
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
1 Year · Not Acquired
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
1 Year · Not Evaluable
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
2 Year · None
|
9 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
2 Year · Trace
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
2 Year · Mild
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
2 Year · Moderate
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
2 Year · Severe
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
2 Year · Not Acquired
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3 Year · Trace
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3 Year · Mild
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3 Year · Moderate
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3 Year · Severe
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3 Year · Not Acquired
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
3 Year · Not Evaluable
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
4 Year · Mild
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
4 Year · Moderate
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
4 Year · Severe
|
1 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
4 Year · Not Acquired
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
4 Year · Not Evaluable
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
5 Year · None
|
4 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
5 Year · Trace
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
5 Year · Mild
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
5 Year · Moderate
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
5 Year · Severe
|
0 Participants
|
|
Degree of Paravalvular Regurgitation From Discharge up to 5 Years
5 Year · Not Evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3-6 Months · None
|
9 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Trace
|
2 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Mild
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Baseline · None
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Baseline · Trace
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Baseline · Mild
|
8 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Baseline · Moderate
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Baseline · Severe
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Baseline · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Baseline · Not Evaluable
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · None
|
10 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Trace
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Mild
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Moderate
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Severe
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Not Evaluable
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Moderate
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Severe
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3-6 Months · Not Evaluable
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
1 Year · None
|
9 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
1 Year · Trace
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
1 Year · Mild
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
1 Year · Moderate
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
1 Year · Severe
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
1 Year · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
1 Year · Not Evaluable
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
2 Year · None
|
9 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
2 Year · Trace
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
2 Year · Mild
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
2 Year · Moderate
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
2 Year · Severe
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
2 Year · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
2 Year · Not Evaluable
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3 Year · None
|
10 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3 Year · Trace
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3 Year · Mild
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3 Year · Moderate
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3 Year · Severe
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3 Year · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
3 Year · Not Evaluable
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
4 Year · None
|
6 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
4 Year · Trace
|
2 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
4 Year · Mild
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
4 Year · Moderate
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
4 Year · Severe
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
4 Year · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
4 Year · Not Evaluable
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
5 Year · None
|
3 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
5 Year · Trace
|
1 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
5 Year · Mild
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
5 Year · Moderate
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
5 Year · Severe
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
5 Year · Not Acquired
|
0 Participants
|
|
Degree of Transvalvular Regurgitation From Discharge up to 5 Years
5 Year · Not Evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · None
|
7 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Trace
|
2 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Mild
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3-6 Month · Mild
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3-6 Month · Moderate
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3-6 Month · Severe
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Baseline · None
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Baseline · Trace
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Baseline · Mild
|
7 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Baseline · Moderate
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Baseline · Severe
|
2 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Baseline · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Baseline · Not Evaluable
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Moderate
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Severe
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
Discharge up to 30 Days · Not Evaluable
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3-6 Month · None
|
7 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3-6 Month · Trace
|
2 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3-6 Month · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3-6 Month · Not Evaluable
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
1 Year · None
|
9 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
1 Year · Trace
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
1 Year · Mild
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
1 Year · Moderate
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
1 Year · Severe
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
1 Year · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
1 Year · Not Evaluable
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
2 Year · None
|
9 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
2 Year · Trace
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
2 Year · Mild
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
2 Year · Moderate
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
2 Year · Severe
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
2 Year · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
2 Year · Not Evaluable
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3 Year · None
|
9 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3 Year · Trace
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3 Year · Mild
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3 Year · Moderate
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3 Year · Severe
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3 Year · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
3 Year · Not Evaluable
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
4 Year · None
|
5 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
4 Year · Trace
|
2 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
4 Year · Mild
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
4 Year · Moderate
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
4 Year · Severe
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
4 Year · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
4 Year · Not Evaluable
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
5 Year · None
|
3 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
5 Year · Trace
|
1 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
5 Year · Mild
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
5 Year · Moderate
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
5 Year · Severe
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
5 Year · Not Acquired
|
0 Participants
|
|
Degree of Total Valvular Regurgitation From Discharge up to 5 Years
5 Year · Not Evaluable
|
1 Participants
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Performance Index (L/Min) From Discharge up to 5 Years
Baseline
|
0.3 L/min
Standard Deviation 0.1
|
|
Performance Index (L/Min) From Discharge up to 5 Years
Discharge up to 30 Days
|
0.6 L/min
Standard Deviation 0.1
|
|
Performance Index (L/Min) From Discharge up to 5 Years
3-6 Month
|
0.5 L/min
Standard Deviation 0.2
|
|
Performance Index (L/Min) From Discharge up to 5 Years
1 Year
|
0.6 L/min
Standard Deviation 0.1
|
|
Performance Index (L/Min) From Discharge up to 5 Years
2 Year
|
0.5 L/min
Standard Deviation 0.1
|
|
Performance Index (L/Min) From Discharge up to 5 Years
3 Year
|
0.6 L/min
Standard Deviation 0.1
|
|
Performance Index (L/Min) From Discharge up to 5 Years
4 Year
|
0.6 L/min
Standard Deviation 0.1
|
|
Performance Index (L/Min) From Discharge up to 5 Years
5 Year
|
0.5 L/min
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
Discharge up to 30 Days
|
4.0 L/min
Standard Deviation 0.8
|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
Baseline
|
4.0 L/min
Standard Deviation 1.3
|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
3-6 Month
|
3.9 L/min
Standard Deviation 0.8
|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
1 Year
|
4.4 L/min
Standard Deviation 0.9
|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
2 Year
|
3.7 L/min
Standard Deviation 0.9
|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
3 Year
|
3.8 L/min
Standard Deviation 0.6
|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
4 Year
|
3.6 L/min
Standard Deviation 0.9
|
|
Cardiac Output (L/Min) From Discharge up to 5 Years
5 Year
|
4.3 L/min
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements.
This will be measured by transthoracic echocardiography technique and will be assessed by an independent core laboratory.
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
Baseline
|
3.0 L/min/m^2
Standard Deviation 0.9
|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
Discharge up to 30 Days
|
3.0 L/min/m^2
Standard Deviation 0.6
|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
3-6 Months
|
3.0 L/min/m^2
Standard Deviation 0.5
|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
1 Year
|
3.3 L/min/m^2
Standard Deviation 0.6
|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
2 Year
|
2.6 L/min/m^2
Standard Deviation 0.6
|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
3 Year
|
2.8 L/min/m^2
Standard Deviation 0.4
|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
4 Year
|
2.6 L/min/m^2
Standard Deviation 0.7
|
|
Cardiac Index (L/Min/m^2) From Discharge up to 5 Years
5 Year
|
3.2 L/min/m^2
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at discharge up to 30 days, 3-6 months, 1 year and annually thereafter up to 5 years.The early (\<=30days post-procedure), late (\>30days post-procedure) and 1-year participant counts of the following valve-related adverse events will be evaluated: * thromboembolism * thrombosis * hemorrhage * paravalvular leak * endocarditis * hemolysis * structural valve deterioration * non-structural dysfunction * reintervention * explant * death
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Safety:Valve-related Adverse Events
Valve-Related Adverse Events
|
0 Participants
|
|
Safety:Valve-related Adverse Events
Valve Reinterventions / Explants
|
0 Participants
|
|
Safety:Valve-related Adverse Events
Valve-Related Deaths
|
0 Participants
|
|
Safety:Valve-related Adverse Events
Structural Valve Deterioration
|
0 Participants
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. No SF-36 quality of life assessment was collected at 5 years.
SF-36 Questionnaire Physical Component Summary (physical functioning, role-physical, bodily pain, general health, vitality) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher physical quality of life. Physical Component Summary Scale Lowest possible score: -7.28 Highest possible score: 52.71
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
Baseline
|
37.4 score on a scale
Standard Deviation 17.3
|
|
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
3-6 Month
|
35.5 score on a scale
Standard Deviation 15.7
|
|
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
1 Year
|
39.2 score on a scale
Standard Deviation 17.3
|
|
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
2 Year
|
39.5 score on a scale
Standard Deviation 13.2
|
|
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
3 Year
|
26.6 score on a scale
Standard Deviation 17.0
|
|
Quality of Life Assessment - Physical Component Summary (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality)
4 Year
|
36.1 score on a scale
Standard Deviation 21.4
|
SECONDARY outcome
Timeframe: This outcome will be evaluated at baseline, 3-6 months, 1 year and annually thereafter up to 5 years.Population: Subject data for this outcome measure is limited by the number of subjects remaining in study at each timepoint and limited to those with non-missing measurements. No SF-36 quality of life assessment was collected at 5 years.
SF-36 Questionnaire Mental Component Summary (social functioning, role-emotional, mental health) at baseline, 3-6 months, 1 year and annually thereafter through 5 years, where a higher score indicates a higher quality of mental life. Lowest possible score: 31.63 Highest possible score: 66.69
Outcome measures
| Measure |
MDT-2215
n=11 Participants
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
Baseline
|
52.0 score on a scale
Standard Deviation 6.1
|
|
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
3-6 Month
|
55.2 score on a scale
Standard Deviation 10.0
|
|
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
1 Year
|
57.3 score on a scale
Standard Deviation 9.9
|
|
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
2 Year
|
57.9 score on a scale
Standard Deviation 6.1
|
|
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
3 Year
|
53.0 score on a scale
Standard Deviation 8.7
|
|
Quality of Life Assessment - Mental Component Summary (Social Functioning, Role-emotional, Mental Health)
4 Year
|
53.5 score on a scale
Standard Deviation 2.1
|
Adverse Events
MDT-2215
Serious events: 2 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
MDT-2215
n=11 participants at risk
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Disorders
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax and Pleural Effusions Nec
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
Other adverse events
| Measure |
MDT-2215
n=11 participants at risk
17mm MDT-2215 aortic valve bioprosthesis
|
|---|---|
|
Blood and lymphatic system disorders
Anemias
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenias
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Cardiac disorders
Supraventricular Arrhythmias
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Cardiac disorders
Ventricular Arrhythmias and Cardiac Arrest
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Investigations
Coagulation and Bleeding Analyses
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Investigations
Digestive Enzymes
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Investigations
Hepatobiliary Function Diagnostic Procedures
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Metabolism and nutrition disorders
Protein Metabolism Disorders
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Psychiatric disorders
Disturbances in Initiating and Maintaining Sleep
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Conditions Associated with Abnormal Gas Exchange
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Mediastinal Disorders
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax and Pleural Effusions
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Vascular disorders
Vascular Hypertensive Disorders
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
|
Infections and infestations
Upper Respiratory Tract Infections
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through study exit, up to 5 years.
|
Additional Information
Jessica Halverson, Clinical Research Director
Medtronic
Phone: (800) 633-8766
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place