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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Long Term PAS

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Study Status Completed
Application Number P140017 / PAS001
Date Current Protocol Accepted 01/27/2015
Study Name Long Term PAS
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 Design Description 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 Description 150 subjects who were successfully implanted in the original

5 IDE centers.

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.

Data Collection 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

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 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.
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.
Patient Follow-up Rate The follow up rate for this study is 85% (128/150).
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

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%

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.
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.

Long Term PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
Final Report 10/01/2015 10/01/2015 On Time

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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