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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P970030 / PAS001 |
| Date Original Protocol Accepted |
11/04/1997
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| Date Current Protocol Accepted |
|
| Study Name |
PAS
|
| Device Name |
TORONTO SPV VALVE
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study was a multi-center, observational, prospective trial, without concurrent or matched controls, conducted under a common protocol. A subset of subjects from the IDE study were followed until 100 subjects reached the endpoint of a minimum of 10 years. The focus of the study was to: 1) evaluate hemodynamic performance of the Toronto SPV valve and 2) monitor occurrence of adverse effects that may occur.
|
| Study Population |
The device is a tissue heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves. This `surveillance study' is a patient device tracking database.
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| Sample Size |
Minimum of 100 patients, 6 sites
|
| Key Study Endpoints |
Study endpoint include death, re-operation and explant rates.
|
| Follow-up Visits and Length of Follow-up |
Patients were to be followed-up at 3-6 months and annually thereafter up to 10 years.
|
| Interim or Final Data Summary |
| Interim Results |
Study completed, see final results.
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| Actual Number of Patients Enrolled |
417 patients
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| Actual Number of Sites Enrolled |
6 sites
|
| Patient Follow-up Rate |
85%
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| Final Safety Findings |
The early rate for all cause death of 0.9% for the post-approval study is significantly lower (better) than the early rate for all cause death of 2.8% for the pre-market study.The linearized late rate for major anticoagulant-related hemorrhage of 0.06%/patient-year for the post-approval study is significantly lower (better) than the linearized late rate for major anticoagulant-related hemorrhage of 0.3%/patient-year for the pre-market study. The linearized late rate for re-operation (including explants) of 1.7%/patient-year for the post-approval study is significantly higher (worse) than the linearized late rate for re-operation (including explants) of 0.3%/patient-year for the pre-market study, but the 1.7%/patientyear post-approval study rate is still acceptable according to the clinical reviewer. This rate is also similar to what is in the published literature. The linearized late rate for all cause death of 4.0%/patient-year for the post-approval study is significantly higher (worse) than the linearized late rate for all cause death of 2.3%/patient-year for the original premarket study, but the 4.0%/patient-year post-approval study rate is still acceptable, according to the clinical reviewer, and more importantly is much less relevant to the Toronto SPV valve evaluation than the acceptable linearized late rate for valve-related death of 0.7%/patient-year for the post-approval study. These rates are also similar to what is in the published literature.
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| Study Strengths & Weaknesses |
Strengths: The study aimed to use the denominator for this post-market surveillance study as all Toronto SPV valve patients in the SJMD Patient Device Tracking database. This would minimize selection bias.
Weaknesses: There were not postmarket study questions outlined for this study.
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| Recommendations for Labeling Changes |
There were no recommendations for changes to the labeling based on the results of the post-approval study.
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