|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P040021 / PAS001 |
| Date Original Protocol Accepted |
08/03/2006
|
| Date Current Protocol Accepted |
08/30/2012
|
| Study Name |
Biocor & Biocor Supra Valves
|
| Device Name |
SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective cohort
|
| Study Population |
Subjects requiring an aortic valve replacement were implanted with either the Biocor aortic valve or the Biocor Supra aortic valve
|
| Sample Size |
A total of 800 patient- years of follow-up with a minimum of 100 patients followed for at least 5 years, enrolled across 25 sites.
|
| Key Study Endpoints |
NYHA, hemolysis, nonstructural dysfunction, paravalvular leak, structural deterioration/failure, bleeding events, embolism, endocarditis, valve thrombosis, reoperation, explant and death (all and valve-related).
|
| Follow-up Visits and Length of Follow-up |
>120 patients would be out 4 years or more, -50-70 patients will be out 6 years or more and of these 25-30 would be out 7 years.
Annually out to 8 years
|
| Interim or Final Data Summary |
| Interim Results |
At one year the majority of subjects report none or trivial hemodynamic insufficiency. There were no mean gradients greater than 14.9 mmHg reported.
|
| Actual Number of Patients Enrolled |
300 (297 subjects met eligibility criteria)
|
| Actual Number of Sites Enrolled |
17
|
| Patient Follow-up Rate |
at 5 years (114 eligible subjects) - 94.7% (108/114)
Overall cumulative follow-up - 959.4 late patient-years (average of 3.2± 1.9 years)
|
| Final Safety Findings |
Early adverse event rate (? 30 days post implant) based on 297 subjects:
Bleeds 7.4% (7.1% major), Deaths 2.4% (0.3% valve-related), Embolism 0.7%, and 0.3% Paravalvular leak.
Linearized late adverse event rate (number per 100 late patient year) based on 959.4 late patient years are as follows:
Bleeds 4.48 (4.17 major), Deaths 3.86 (0.52 valve-related), Reoperation 1.36, Endocarditis 1.04, Embolism 0.83 (TIA 0.52, stroke 0.10), Nonstructural dysfunction 0.42, Structural deterioration 0.31, and Thrombosis 0.10.
The rates of freedom from event at 5 years post implant by Kaplan Meier analysis are
Structural valve deterioration - 97.7% Reoperation- 94.2%
Valve-related mortality- 97.5% Bleeding Event ? 76.1% Embolism- 95.2%
Endocarditis- 96.1%
|
| Final Effect Findings |
The proportion of subjects in NYHA class I or II at 5 years: all Biocor valve positions - 91.5% (97/106), Aortic position - 93.1% (41/44), Aortic Supra position - 90.9% (40/44) and Mitral position- 88.9% (16/18)
|
| Study Strengths & Weaknesses |
The study achieved a high follow-up rate of 94.7% at 5-year post implant, and an overall follow-up of
959.4 late patient years greater than the expected 800 late patient years. At least 100 patients were
followed out to 5 years as required per protocol.
Weaknesses
This was a single arm study without a comparator. Thus, the study result was not evaluated by a formal statistical test.
|
| Recommendations for Labeling Changes |
Labeling change is recommended to reflect the long term data from the post-approval study. The labeling change should include a new section on the label showing a summary of the post-approval study methods (including study objectives, design, population, number of enrolled sites/subjects, key endpoints, follow ?up visits etc.), final results and study strengths and limitations of the PAS.
|
