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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140017 / PAS001 |
| Date Original Protocol Accepted |
01/27/2015
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| Date Current Protocol Accepted |
01/27/2015
|
| Study Name |
Long Term PAS
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| Device Name |
MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Analytical
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| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, non-randomized, multi-center study,
historically controlled clinical trial, designed to follow up subjects from the IDE trial up to five years
|
| Study Population |
150 subjects who were successfully implanted in the original
5 IDE centers.
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| Sample Size |
150 subjects who were successfully implanted in the original
5 IDE centers. The five U.S. IDE centers are continuing their participation in the study for the required five-year follow- up period for enrolled subjects..
Using a power of 80%, a one-tailed alpha of 5%, and an estimated freedom from TPV dysfunction at 5 years of 47%, the calculated required sample size for the 5 year study comes to 133. The sponsor does not estimate the effect of subjects lost to follow-up on the final 5 year study population.
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| Key Study Endpoints |
Primary Endpoints
TPV dysfunction is the primary endpoint. It is defined as either:
¿Þ RVOT reoperation for conduit dysfunction or device- related reason OR
¿Þ Catheter re-intervention on the TPV OR
¿Þ Hemodynamic dysfunction of the TPV (moderate or greater pulmonary regurgitation, and/or a mean RVOT gradient greater than 40 mm Hg)
Secondary Endpoints
¿Þ Percent patients with procedural success
¿Þ Percent subjects with serious procedural adverse events
¿Þ Percent subjects with serious device-related adverse events
¿Þ Stent fracture
¿Þ Re-intervention on the TPV
¿Þ Surgical replacement of the RVOT conduit
¿Þ Death
o All-cause
o Procedure-related
o Device-related
¿Þ NYHA classification
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| Follow-up Visits and Length of Follow-up |
5 years
Annually until followed for 5 years
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
There is no new enrollment for this study, as it involves only follow-up of the premarket cohort. However, a total of 150 subjects who received the Melody Transcatheter Pulmonary Valve (TPV) device.
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| Actual Number of Sites Enrolled |
There are no new study sites for this study, as it involves only study subjects from the premarket cohort. The study subjects were enrolled at five (5) sites in the premarket study.
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| Patient Follow-up Rate |
The follow up rate for this study is 85% (128/150).
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| Final Safety Findings |
21 subjects experienced 30 serious procedure related adverse events
47 subjects experienced 86 serious device related adverse events
23 stent fractures, with 13 occurring in years 2 or 3, and 3 or less in all other years
29 catheter related re-interventions
15 RVOT conduit reoperations
6 deaths
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| Final Effect Findings |
Freedom from TPV dysfunction at 5 years after TPV implant was 74.2%, by K-M analysis, with a 95%
confidence interval ranging from 65.5% to 81.0%
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| Study Strengths & Weaknesses |
This study provides longer term (5 years) safety and effectiveness results of the Melody Transcatheter Pulmonary Valve (TPV) device. This study followed up the premarket cohort through five years post- procedure. Kaplan-Meier analysis of the primary endpoint, freedom from TPV dysfunction, estimates a rate of 72% at 5 years. This compares very favorably with the performance goal of 36%. The study had a low rate of attrition (7/150), thus minimizing selection bias. At the same time the study had 86 serious device related adverse events. Considering the fact that this device precludes the need for major surgery, this relatively high number of serious device related adverse events does not represent an unreasonable risk for the long term safety and effectiveness of the Melody TPV device.
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| Recommendations for Labeling Changes |
Labeling changes are recommended to add a summary of the 5-year study results including the complete and updated Kaplan-Meier analysis. The updated labeling will reflect the long-term (5-years) performance of the device.
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