|
General |
Study Status |
Completed |
Application Number / Requirement Number |
P860057 S042/ PAS001 |
Date Original Protocol Accepted |
11/03/2009
|
Date Current Protocol Accepted |
11/03/2009
|
Study Name |
Clinical Study
|
Device Name |
CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
New Data Collection
|
Comparison Group |
Objective Performance Criterion
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Interim or Final Data Summary |
Actual Number of Patients Enrolled |
258
|
Actual Number of Sites Enrolled |
14
|
Patient Follow-up Rate |
98% For the 258 patients implanted with the Magna Ease aortic valve, mean follow-up was 6.2 ± 2.4 years, range of follow-up was 0 – 8.2 years, and total cumulative follow-up was 1597.6 patient-years. There were 1576.6 late patient-years of follow-up for the implanted patients.
|
Final Safety Findings |
The study device was found to meet all Objective Performance Criteria with the exception of Bleeding (All and Major) in which the upper 95% confidence limit was above 2xOPC (3.4 vs 2.8 for All Bleeding and 1.9 vs 1.8 for Major Bleed). This results are acceptable when considering the cause of bleed for affected patients. The Kaplan-Meier rate for Freedom from Structural Valve Deterioration (SVD) was 90.1% at 8 years.
|
Final Effect Findings |
At all follow-up timepoints out to 8 years 93.9% of patients were NYHA Class I or Class II. At 8 years, 88.6% of patients had trivial or none regurgitation and 10.2% of patients had mild regurgitation. No patients were reported with severe regurgitation at any timepoint. Of patients that had regurgitation, most were central regurgitation rather than perivalvular.
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Study Strengths & Weaknesses |
Strengths of the study included the overall follow-up of patients through mid-term durations (8 years) to collect 1576.6 late patient-years of follow-up for the implanted patients. Weaknesses of the study include that the study was a single-arm trial which is true for most recent surgical valve studies. Additionally, the final dataset was limited by missing echocardiograms for various timepoints throughout the study.
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Recommendations for Labeling Changes |
The sponsor should update their labeling to reflect the results obtained in the completed study.
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