|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P860057 S029/ PAS001 |
| Date Original Protocol Accepted |
12/05/2008
|
| Date Current Protocol Accepted |
01/24/2014
|
| Study Name |
Long Term
|
| Device Name |
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX
|
| 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
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A prospective, single-arm, multi-center study that will enroll a
minimum of 250 patients implanted with the Carpentier-Edwards PERIMOUNT 7000 TFX, 72000 TFX and 73000 TFX, Magna Ease, Model 3300TFX, in order to achieve 101/Aortic valve replacement subjects each followed for a minimum of 8 years.
A new enrollment study.
|
| Study Population |
Study Population: Patients must be at least 18 years of age
eligible for mitral valve replacement. Indication: It is intended for patients who require replacement of their diseased, damaged or malfunctioning native or prosthetic aortic valve and whose prognosis without aortic valve replacement is unacceptably poor.
No comparator group.
|
| Sample Size |
A minimum of 250/Subjects at up to 25/Sites in order to obtain a
minimum of 8 years data on 101 subjects.
|
| Key Study Endpoints |
Endpoints include thrombo-embolism, perivascular leak,
hemorrhage, endocarditis, and heart failure. Early AE (within 30 days of implant) are summarized as the percent (events
/subjects) of subjects experiencing an early event. Late post- operative AE (>30 days post-implant) are summarized in terms of linearized rates (events /patient years).
|
| Follow-up Visits and Length of Follow-up |
8 years - Patients will be followed at discharge, 6-months, one year, and annually thereafter for a minimum of 8 years.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
329
|
| Actual Number of Sites Enrolled |
19
|
| Patient Follow-up Rate |
The study met its minimum required follow-up target of 101 patients for 8 years of follow-up. Of the 329 implanted patients, 109 patients completed follow-up through 8 years.
|
| Final Safety Findings |
The study device was found to meet all Objective Performance Criteria with the exception of Bleeding in which the upper 95% confidence limit was above 2xOPC (6.9 vs 2.8 for All Bleeding). These results are acceptable when considering the cause of bleed for affected patients. The Kaplan-Meier rate for Freedom from Structural Valve Deterioration (SVD) was 83.7% at 8 years.
|
| Final Effect Findings |
At all follow-up timepoints out to 8 years 87.7% of patients were NYHA Class I or Class II. At 8 years, 77.9% of patients had trivial or none central regurgitation and 22.1% of patients had mild regurgitation. No patients had moderate or severe central regurgitation or PVL at 8 years.
|
| Study Strengths & Weaknesses |
Strengths of the study included the overall follow-up of patients through 8 years (109 patients completed 8-year follow-up).
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 NYHA data at 8-years.
|
| Recommendations for Labeling Changes |
Labeling update is recommended
|
