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General |
Study Status |
Terminated |
Application Number / Requirement Number |
H080002 / PAS002 |
Date Original Protocol Accepted |
04/06/2010
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Date Current Protocol Accepted |
09/24/2013
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Study Name |
Generalizability Study
|
Device Name |
MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM
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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,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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Detailed Study Protocol Parameters |
Study Objectives |
This is a prospective, observational, non-randomized, multi-center study. The study purpose is to confirm the short-term hemodynamic effectiveness results achieved by real world providers are equivalent to the historical control established in the IDE study. Where the percentage of subjects with acceptable TPV hemodynamic function at six months after Melody valve implantation will be assessed.
|
Study Population |
Consecutive subjects at each site will be invited to participate in the study if they meet the indication for the device. This include the eExistence of a full right ventricular outflow tract conduit that was equal to or greater than 16 mm in diameter when originally implanted, and dysfunction ight ventricular outflow tract conduits with a clinical indication for intervention, including moderate or severe regurgitation or stenosis with and ight ventricular outflow tract gradient of at least 35 mmHg.
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Sample Size |
100 patients, 10-15 sites
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Key Study Endpoints |
The primary endpoint is the percentage of subjects with acceptable hemodynamic function at six months post-implant.
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Follow-up Visits and Length of Follow-up |
Follow-up of the clinical endpoints will be conducted at baseline (pre-implant), discharge from the hospital, at six months post-implant, one year, and annually thereafter, until the patient has been followed for five years or until the device has been explanted.
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Interim or Final Data Summary |
Interim Results |
No safety data is available for this study.
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