|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P140017 / PAS002 |
| Date Original Protocol Accepted |
01/27/2015
|
| Date Current Protocol Accepted |
01/27/2015
|
| Study Name |
New Enrollment Study
|
| 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
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, non-randomized, multi-center study.
|
| Study Population |
100 subjects who were successfully implanted in this study
will continue to be followed
|
| Sample Size |
100 subjects: Using a power of 80%, an alpha of 5%, a one-
tailed test, and assuming an estimated rate of 86% (the rate found in the premarket study), the required sample size comes out to 81. Therefore, a sample size of 100 with only six months follow-up will ensure that a sufficient number of patients are followed for the entirety of the study.
|
| Key Study Endpoints |
Primary Endpoints
As noted in the study hypothesis, above, the primary endpoint is the percentage of subjects with acceptable hemodynamic function at six months post-implant. Acceptable hemodynamic function is defined as:
¿Þ Mean RVOT gradient less than or equal to 30 mmHg AND
¿Þ Less than moderate severity of pulmonary regurgitation
AND
¿Þ No RVOT conduit reoperation or catheter re-intervention
since implant
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 at 6 months post-implant
¿Þ Incidence of serious device-related adverse events during full follow-up period
¿Þ Stent fracture
¿Þ Re-intervention on the TPV
¿Þ RVOT conduit reoperation
¿Þ Death
¿X All-cause
¿X Procedure-related
¿X Device-related
¿Þ NYHA classification
|
| Follow-up Visits and Length of Follow-up |
5 years
Annually until followed for 5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
One hundred thirty-one (131)
|
| Actual Number of Sites Enrolled |
Ten (10)
|
| Patient Follow-up Rate |
The follow-up rate at 5 years excluding deaths and withdrawals is 67% (=65/97)
|
| Final Safety Findings |
23 subjects (19%, 23/121) experienced 30 serious procedure related adverse events
Of the 100-implanted subjects, 33 subjects (33%) experienced 78 serious device related adverse events. The most common serious adverse events classified as device-related were:
endocarditis (n=17 subjects (13 pediatric + 4 adult))
valve dysfunction: recurrent stenosis (n=12)
valve dysfunction: regurgitation (n=9)
major stent fracture (n=6)
2 device unrelated deaths were reported in this study
|
| Final Effect Findings |
Procedural success was demonstrated in 91.1% of subjects. Kaplan-Meier (K-M) analyses were performed to assess freedom from stent fracture, catheter reintervention, reoperation, and mortality. At 5 years post-implant, freedom from major stent fracture was 93.0%, catheter reintervention was 92.8%, reoperation was 82.4%, and all-cause mortality was 97.5%. There were no procedure or device related deaths. The NYHA class improved significantly from baseline to 6 months post-implant and during the final follow up at 5 years, with 37.9% of subjects in class I at baseline, and 85.5% of subjects in class I at 6 months.
|
| Study Strengths & Weaknesses |
Study Strength: The primary objective of the study was to confirm that the short-term hemodynamic effectiveness of implantation of the Melody™ TPV at six months post-implant is equal to or greater than the Performance Goal (PG)of 75%, established based on the performance of this device in the IDE study.. The primary objective was met with 96.7% ()of subjects having acceptable hemodynamic function 6 months post-implant (p-value < 0.0001 and 95% lower confidence bound of 91.6%) which compares very favorably with the PG.
Study Weaknesses: The study had a lower rate of follow up (67%) and a higher rate of attrition (33.7%), that may be subject to selection bias. Further, during the duration of this study the study protocol was modified to allow for the phone call visits from 2 to 5 years resulting in the number of subjects with echocardiographic data less than the total number of subjects for whom follow-up data were collected for years 2 through 5. Also, the study had 78 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.
|
| Recommendations for Labeling Changes |
Labeling changes are recommended to add a summary of the 5-year study results reflecting the long-term (5-years) performance of the device.
|
