Trial Outcomes & Findings for Melody® Transcatheter Pulmonary Valve Post-Approval Study (NCT NCT01186692)
NCT ID: NCT01186692
Last Updated: 2019-05-01
Results Overview
Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.
COMPLETED
NA
131 participants
6 months
2019-05-01
Participant Flow
Participant milestones
| Measure |
Enrolled
All subjects enrolled (n=131)
|
|---|---|
|
Overall Study
STARTED
|
131
|
|
Overall Study
COMPLETED
|
99
|
|
Overall Study
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Enrolled
All subjects enrolled (n=131)
|
|---|---|
|
Overall Study
Not Catheterized
|
11
|
|
Overall Study
Futher testing contraindicated implant
|
19
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Melody® Transcatheter Pulmonary Valve Post-Approval Study
Baseline characteristics by cohort
| Measure |
Enrolled Cohort
n=131 Participants
All subjects enrolled.
|
|---|---|
|
Age, Continuous
|
20.1 years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
131 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable echo data at 6 months post implant were included in the analysis.
Acceptable TPV hemodynamic function at six months after successful TPV implantation is determined as a composite of the following: * Mean RVOT gradient is less than or equal to 30 mmHg as measured by CW Doppler, and * Severity of pulmonary regurgitation is less than moderate by Doppler echocardiography, and * Free from RVOT conduit reoperation or catheter re-intervention at six months after TPV implantation. The endpoint is defined as the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation.
Outcome measures
| Measure |
Implanted >24 Hours Cohort
n=90 Participants
The implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
|
|---|---|
|
Acceptable TPV Hemodynamic Function at Six Months After Successful TPV Implantation
|
96.7 percentage of patients
Interval 91.6 to 100.0
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
Procedural success is defined as a composite of the following: * The TPV is fixated within the desired location, and * The RV-PA peak-to-peak gradient measured in the catheterization lab after TPV implantation is less than 35 mmHg, and * There is no more than trivial pulmonary regurgitation by angiography * The subject is free from explantation of the TPV at 24 hours post-implant
Outcome measures
| Measure |
Implanted >24 Hours Cohort
n=101 Participants
The implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
|
|---|---|
|
Procedural Success
|
92.1 percentage of patients
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
A procedure-related event is defined as an event that is associated with the implant procedure by the chronology or physiology and was caused by the implant procedure (e.g. rupture of the conduit or damage to an intra-cardiac or intravascular structure by the delivery system).
Outcome measures
| Measure |
Implanted >24 Hours Cohort
n=120 Participants
The implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
|
|---|---|
|
Serious Procedural Adverse Events
|
19.2 percentage of patients
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
A device-related event is defined as an event that is associated with the TPV by the chronology or physiology and was caused by the the TPV (e.g. embolization of the TPV and any adverse events which follow).
Outcome measures
| Measure |
Implanted >24 Hours Cohort
n=100 Participants
The implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
|
|---|---|
|
Serious Device-related Adverse Events
|
11.0 percentage of patients
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: The implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours. Of this population those with evaluable paired NYHA data were included in the analysis.
Change in NYHA functional class from pre-implant to 6 month post-implant
Outcome measures
| Measure |
Implanted >24 Hours Cohort
n=99 Participants
The implanted \>24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
|
|---|---|
|
Changes in NYHA Functional Classification
Changes in NYHA Functional Classification
|
93 participants
|
|
Changes in NYHA Functional Classification
Improved
|
51 participants
|
|
Changes in NYHA Functional Classification
No Change
|
39 participants
|
|
Changes in NYHA Functional Classification
Worsened
|
3 participants
|
Adverse Events
Catheterized Cohort
Serious adverse events
| Measure |
Catheterized Cohort
n=120 participants at risk
The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemias NEC
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Blood and lymphatic system disorders
Haematological disorders
|
0.83%
1/120 • Number of events 2 • 6 months
|
|
Cardiac disorders
Cardiac disorders NEC
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Cardiac disorders
Coronary artery disorders NEC
|
0.83%
1/120 • Number of events 2 • 6 months
|
|
Cardiac disorders
Pulmonary valvular disorders
|
2.5%
3/120 • Number of events 3 • 6 months
|
|
Cardiac disorders
Rate and rhythm disorders NEC
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Cardiac disorders
Supraventricular arrhythmias
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Cardiac disorders
Ventricular arrhythmias and cardiac arrest
|
1.7%
2/120 • Number of events 9 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders NEC
|
1.7%
2/120 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Nausea and vomiting symptoms
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
diarrhoea (excl infective)
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
General disorders
Device issues NEC
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
General disorders
Device physical property and chemical issues
|
7.5%
9/120 • Number of events 10 • 6 months
|
|
General disorders
Febrile disorders
|
1.7%
2/120 • Number of events 3 • 6 months
|
|
General disorders
Therapeutic and nontherapeutic responses
|
3.3%
4/120 • Number of events 9 • 6 months
|
|
Infections and infestations
Cardiac infections
|
2.5%
3/120 • Number of events 5 • 6 months
|
|
Infections and infestations
Lower respiratory tract and lung infections
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Infections and infestations
Sepsis, bacteraemia, viraemia and fungaemia NEC
|
0.83%
1/120 • Number of events 2 • 6 months
|
|
Injury, poisoning and procedural complications
Cardiac and vascular procedural complications
|
0.83%
1/120 • Number of events 1 • 6 months
|
|
Injury, poisoning and procedural complications
Non-site specific procedural complications
|
3.3%
4/120 • Number of events 5 • 6 months
|
|
Nervous system disorders
Nervous system disorders NEC
|
0.83%
1/120 • Number of events 3 • 6 months
|
|
Nervous system disorders
Neurological signs and symptoms NEC
|
0.83%
1/120 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax and pleural effusions NEC
|
0.83%
1/120 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary thrombotic and embolic conditions
|
0.83%
1/120 • Number of events 2 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract disorders NEC
|
3.3%
4/120 • Number of events 5 • 6 months
|
|
Vascular disorders
Non-site specific embolism and thrombosis
|
1.7%
2/120 • Number of events 5 • 6 months
|
|
Vascular disorders
Vascular injuries NEC
|
0.83%
1/120 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Catheterized Cohort
n=120 participants at risk
The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
|
|---|---|
|
General disorders
Pain and discomfort NEC
|
6.7%
8/120 • Number of events 9 • 6 months
|
|
General disorders
Therapeutic and nontherapeutic responses
|
6.7%
8/120 • Number of events 13 • 6 months
|
|
Infections and infestations
Infections NEC
|
5.8%
7/120 • Number of events 8 • 6 months
|
|
Injury, poisoning and procedural complications
Non-site specific procedural complications
|
6.7%
8/120 • Number of events 8 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A publication committee is in place for this study.
- Publication restrictions are in place
Restriction type: OTHER