|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100029 / PAS001 |
| Date Original Protocol Accepted |
04/20/2011
|
| Date Current Protocol Accepted |
04/20/2011
|
| Study Name |
Trifecta Valve PAS
|
| Device Name |
ST JUDE MEDICAL TRIFECTA VALVE
|
| 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 study is a multi-center, prospective, non-randomized,
post-approval study conducted in the United States
|
| Study Population |
Subjects previously implanted with a Trifecta prosthetic valve at the selected sites during the IDE clinical investigational study and meet all eligibility criteria for this clinical study will be invited to participate.
|
| Sample Size |
The study will enroll approximately 300 subjects enrolled from approximately 6 U.S. sites that enrolled subjects in the Trifecta¿ valve IDE study to result in a minimum of one-hundred-sixty (160) subjects followed for five (5) years from their Trifecta implant procedure.
|
| Key Study Endpoints |
Primary Endpoints: Late endocarditis and embolism (linearized) rates as compared to the FDA Draft Replacement Heart Valve Guidance Objective Performance Criteria (OPC).
Secondary Endpoints: valve thrombosis, major bleed, all
paravalvular leak, major paravalvular leak, reoperation, explants,
non-structural dysfunction, structural deterioration, valve related
death, embolism, endocarditis, valve thrombosis, major bleed, all paravalvular leak, major paravalvular leak, reoperation, explants, nonstructural dysfunction, structural deterioration and valve-related death, New York Heart Association (NYHA) functional classification status at each interval, and hemodynamic performance at each interval.
|
| Follow-up Visits and Length of Follow-up |
Five-years post implant
Annual
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
245
|
| Actual Number of Sites Enrolled |
6
|
| Patient Follow-up Rate |
94.7%
|
| Final Safety Findings |
No Unanticipated Adverse Device Effects (UADE¿s) was reported during the continued follow-up study period. The linearized thromboembolism and endocarditis rates are statistically significantly lower than the FDA 1994 Draft Replacement Heart Valve Guidance Objective Performance Criteria (OPC).
|
| Final Effect Findings |
At 5-year visit, over 90% patients maintained at NYHA I level, and valve insufficiency was classified as either none, trivial, or mild for 98.2% of patients.
|
| Study Strengths & Weaknesses |
Strength: long-term follow-up (5 years) with over 94.7% of follow-up rate
Weakness: The study population consisted of subjects from the premarket cohort. Premarket studies
are typically characterized by providers who are exceptionally skilled; and are therefore likely to provide relatively good results
|
| Recommendations for Labeling Changes |
Because neither safety nor effectiveness data presented in the final report substantially alter the labeling already approved for the Trifecta Valve, the labeling updates for Trifecta Valve is not recommended
|
