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|
| General |
| Study Status |
Other |
Application Number /
Requirement Number |
P060025 / PAS001 |
| Date Original Protocol Accepted |
10/30/2008
|
| Date Current Protocol Accepted |
10/13/2015
|
| Study Name |
ATS 3f
|
| Device Name |
ATS 3F AORTIC BIOPROSTHESIS
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| 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 |
This is a multi-center, non-randomized trial, registry study designed to follow at least 101 patients for 6 years (obtaining at least 606 patient years). The study will evaluate if there an increased incidence and risk of aortic regurgitation in a patient population 70 years of age or younger implanted with the ATS Medical, Inc., ATS 3f Aortic bioprosthesis, Model 1000 (Equine Pericardial bioprosthesis) undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis.
|
| Study Population |
For patients undergoing isolated aortic valve replacement of his / her native aortic valve, or replacement of a failed prosthesis who are 70 years of age or younger at implant.
|
| Sample Size |
101 patients 70 years of age or less across 8 sites
|
| Key Study Endpoints |
Hemodynamic performance, specifically the proportion of regurgitation, will be used to evaluate the safety of the valve. Hemodynamic performance will be evaluated with doppler echocardiographic studies at 3-6 months, 11-14 months and annually up to the 6 year postoperative evaluation. Values of mean gradient, peak gradient, EOA, EOA index (EOA/body surface area), performance index (EOA/pre-implant internal orifice area), CO, CO index, and valvular regurgitation will be presented.
|
| Follow-up Visits and Length of Follow-up |
Patients will be enrolled and followed preoperative, operative, at discharge (or postoperatively at less than 30 days, whichever comes last), 3-6 months, 11-14 months and annually (plus/minus 2 months) thereafter until they reach the six years follow-up visit. Doppler echocardiography is required at 3-6 months, 11-14 months and annually up to the 6 year postoperative evaluation.
|
| Interim or Final Data Summary |
| Interim Results |
A total of 5 patients have been enrolled and implanted with the study device. Three (3) incidences of regurgitation were reported: 2 perivalvular leaks and 1 nonstructural valve dysfunction - valve bioprosthesis mismatch.
|
| Actual Number of Patients Enrolled |
34; There were 26 eligible subjects implanted with the Model 1000 valve including 14 prospectively enrolled subjects and 12 retrospectively enrolled subjects.
|
| Actual Number of Sites Enrolled |
8
|
| Patient Follow-up Rate |
90.9% at 4 years, 85.7% at 5 years
|
| Final Safety Findings |
Adjudicated Events
Non Structural dysfunction 3, major perivalvular leak 3, Structural valve deterioration 2, Thromboembolism 5, bleeding event 1, severe respiratory sepsis with hypovolemic shock 1
Explants 6,
Other Events: Reoperation 3
|
| Final Effect Findings |
Six (6) of 26 (23.1%) study subjects, experienced aortic regurgitation (AR) of moderate or greater severity. Among these 6 subjects, the moderate or greater regurgitation was transvalvular in 5 subjects and perivalvular in 1 subject, and these regurgitations required valve explant in 5 subjects.
|
| Study Strengths & Weaknesses |
The study experienced difficulty with recruiting eligible subjects
|
| Recommendations for Labeling Changes |
None
|
