Trial Outcomes & Findings for Melody PB1016 Surveillance Study (NCT NCT02347189)

Last Updated: 2019-11-06

Results Overview

Acceptable TPV hemodynamic function at six months after successful TPV implantation which is determined as a composite of the following: * Mean Right Ventricular Outflow Tract (RVOT) gradient is less than or equal to 30 mmHg as measured by Continuous-wave Doppler (CW Doppler) echocardiography, and * Severity of pulmonary regurgitation less than moderate by CW Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at six months post-TPV implantation

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

6 Months

Results posted on

2019-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Melody PB1016 Subjects Consented (i.e. Enrolled) This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
Overall Study STARTED	39
Overall Study Catheterized	39
Overall Study Implanted	30
Overall Study Implanted > 24 Hours	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Melody PB1016 Subjects Consented (i.e. Enrolled) This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
Overall Study No implant attempted of study device	9
Overall Study No primary outcome data available	2

Baseline Characteristics

Melody PB1016 Surveillance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Melody PB1016 Subjects Consented (i.e. Enrolled) n=39 Participants This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
Age, Continuous	15.2 years STANDARD_DEVIATION 6.3 • n=99 Participants
Sex: Female, Male Female	14 Participants n=99 Participants
Sex: Female, Male Male	25 Participants n=99 Participants
Region of Enrollment Canada	3 participants n=99 Participants
Region of Enrollment Austria	4 participants n=99 Participants
Region of Enrollment United States	29 participants n=99 Participants
Region of Enrollment Spain	3 participants n=99 Participants

PRIMARY outcome

Timeframe: 6 Months

Population: 28 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 6 months.

Outcome measures

Outcome measures
Measure	Implanted > 24 Hours Cohort n=28 Participants Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.	Catheterized Cohort: Procedure-related SAEs at 2 Yrs Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.	Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.	Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.
Number of Subjects With Acceptable TPV Hemodynamic Function At 6 Months	25 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 Year

Population: 25 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 1 year.

Acceptable TPV hemodynamic function at 1 year after successful TPV implantation which is determined as a composite of the following: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 1 year post-TPV implantation.

Outcome measures

Outcome measures
Measure	Implanted > 24 Hours Cohort n=25 Participants Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.	Catheterized Cohort: Procedure-related SAEs at 2 Yrs Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.	Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.	Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.
Number of Subjects With Acceptable TPV Hemodynamic Function At 1 Year	23 Participants	—	—	—

SECONDARY outcome

Timeframe: 2 Years

Population: 27 subjects successfully implanted for greater than 24 hours (out of 30 total) had evaluable data at 2 years.

Acceptable TPV hemodynamic function at 2 years after successful TPV implantation which is determined as a composite of the following: * Mean RVOT gradient is ≤ 30 mmHg as measured by CW Doppler * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography * Free from RVOT conduit reoperation or catheter re-intervention on the TPV at 2 years post-TPV implantation.

Outcome measures

Outcome measures
Measure	Implanted > 24 Hours Cohort n=27 Participants Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.	Catheterized Cohort: Procedure-related SAEs at 2 Yrs Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.	Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.	Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.
Number of Subjects With Acceptable TPV Hemodynamic Function at 2 Years	25 Participants	—	—	—

SECONDARY outcome

Timeframe: 1 Year, 2 Years

* Serious procedure-related adverse events at 1year and 2 years post-implant * Serious device-related adverse events at 1 year and 2 years post-implant

Outcome measures

Outcome measures
Measure	Implanted > 24 Hours Cohort n=39 Participants Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.	Catheterized Cohort: Procedure-related SAEs at 2 Yrs n=39 Participants Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.	Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr n=30 Participants Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.	Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs n=30 Participants Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.
Number of Subjects With Serious Procedure-related and Device-related Adverse Events	8 Participants	8 Participants	1 Participants	3 Participants

SECONDARY outcome

Timeframe: At Time Of Procedure

Population: In one subject, the right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient was not collected, leaving the overall number of evaluable subjects analyzed at 29 versus 30.

A successful implant is defined as follows: * Melody TPV PB1016 is fixated within the desired location * RV-PA peak-to-peak gradient measured in the catheterization lab after Melody TPV PB1016 implantation is \< 35 mmHg * No more than trace/trivial pulmonary regurgitation by angiography * Subject is free from explantation of the Melody TPV PB1016 at 24 hours post-implant.

Outcome measures

Outcome measures
Measure	Implanted > 24 Hours Cohort n=29 Participants Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.	Catheterized Cohort: Procedure-related SAEs at 2 Yrs Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.	Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.	Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.
Number of Subjects With Procedural Success	25 Participants	—	—	—

SECONDARY outcome

Timeframe: 2 years

* Kaplan-Meier: Freedom from Stent Fracture * Kaplan-Meier: Freedom from re-intervention on the Melody TPV PB1016 * Kaplan-Meier: Freedom from RVOT Conduit Operation * Kaplan-Meier: Freedom from Death (All-Cause)

Outcome measures

Outcome measures
Measure	Implanted > 24 Hours Cohort n=28 Participants Subjects included in this analysis were those who were successfully implanted with a Melody TPV PB1016 for greater than 24 hours and had evaluable data at 6 months.	Catheterized Cohort: Procedure-related SAEs at 2 Yrs n=30 Participants Subjects included in this analysis were those who went to the catheterization lab for implantation of a Melody PB1016.	Implanted > 24 Hours Cohort: Device-related SAEs at 1 yr n=30 Participants Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.	Implanted > 24 Hours Cohort: Device-related SAEs at 2 Yrs n=30 Participants Subjects included in this analysis were those who were implanted with the Melody PB1016 \> 24 hours.
Percentage of Participants Who Met Various Safety Parameters of the Melody TPV PB1016	96.4 percentage of subjects	96.7 percentage of subjects	100 percentage of subjects	96.7 percentage of subjects

Adverse Events

Melody PB1016 Subjects Consented (i.e. Enrolled)

Serious events: 14 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Melody PB1016 Subjects Consented (i.e. Enrolled) n=39 participants at risk This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
Cardiac disorders Atrial Flutter	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Cardiac Arrest	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Cardiac Disorder	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Congestive Heart Failure	2.6% 1/39 • Number of events 2 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Junctional Rhythm	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Pulmonary Valve Stenosis	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Sinus Bradycardia	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Supraventricular Tachycardia	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Ventricular Tachycardia	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
General disorders Device Complication	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
General disorders Device Rupture	7.7% 3/39 • Number of events 3 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Infections and infestations Endocarditis	7.7% 3/39 • Number of events 3 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Infections and infestations Prosthetic Valve Endocarditis	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Infections and infestations Sepsis	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Injury, poisoning and procedural complications Procedural Hemorrhage	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Nervous system disorders Central Nervous System Disorder*	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Respiratory, thoracic and mediastinal disorders Apnea	2.6% 1/39 • Number of events 1 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	2.6% 1/39 • Number of events 2 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.

Other adverse events

Other adverse events
Measure	Melody PB1016 Subjects Consented (i.e. Enrolled) n=39 participants at risk This study is comprised of a single arm of subjects consented (i.e. enrolled) into the trial. All enrolled subjects were intended to be treated with the Melody TPV PB1016 device. Not all subjects enrolled ultimately received the device.
Cardiac disorders Congestive Heart Failure	5.1% 2/39 • Number of events 2 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Cardiac disorders Tricuspid Regurgitation	7.7% 3/39 • Number of events 3 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Gastrointestinal disorders Gastrointestinal Disorder	7.7% 3/39 • Number of events 5 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Gastrointestinal disorders Vomiting	5.1% 2/39 • Number of events 2 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
General disorders Adverse Event	17.9% 7/39 • Number of events 9 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
General disorders Chest Pain	7.7% 3/39 • Number of events 3 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Infections and infestations Upper Repiratory Tract Infection	5.1% 2/39 • Number of events 2 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Injury, poisoning and procedural complications Vascular Access Complication	5.1% 2/39 • Number of events 2 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Respiratory, thoracic and mediastinal disorders Atelectasis	5.1% 2/39 • Number of events 2 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.
Respiratory, thoracic and mediastinal disorders Respiratory Disorder	7.7% 3/39 • Number of events 4 • Adverse Event data are collected from the point of enrollment (consent signed) through a subject's 2 year visit. Serious Adverse Event: 1. led to death, 2. led to a serious deterioration in the health of the subject, resulting in 1. a life-threatening illness or injury or 2. a permanent impairment of a body structure or a body function or 3. in-patient or prolonged hospitalization or 4. medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function 3. led to foetal distress, death or congenital abnormality/birth defect.

Additional Information

Megan Mueller, Clinical Research Manager

Medtronic

Phone: 612-916-4771

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60