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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P010041 / PAS001 |
| Date Original Protocol Accepted |
06/24/2002
|
| Date Current Protocol Accepted |
06/24/2002
|
| Study Name |
Long term
|
| Device Name |
CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC)
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A five-year clinical study was designed and included two cohorts: 1) A retrospective cohort of patients who were eligible for inclusion in this study, were part of the IDE studies and received an aortic SAV valve between January 1991 and December 1992 at three Canadian sites, and 2) A prospective cohort of newly enrolled patients who received an aortic SAV valve implant after the May 24, 2002.
|
| Study Population |
The study population consisted of all eligible patients who were contacted for follow-up from the pre-market study #99-03 and agreed to participate and a new group of eligible patients who received SAV valve implants after May 24, 2002 (study #2007-07). There were six sites.
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| Sample Size |
160 patients, 6 sites.
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| Key Study Endpoints |
There were four outcome variables: (1) Cardiovascular complications: Assessed according to 1996 Society of Thoracic Surgeons Guidelines; (2) Valve-induced hemolysis: based on findings of the complete blood count (red blood cell count, white blood cell count, platelet count, hemoglobin, hematocrit, haptoglobin, reticulocyte count, serum lactate dehydrogenase); (3) Patient functional classification: using New York Heart Association (4) Hemodynamic performance (Doppler echocardiographic study): All echocardiograms were performed via the transthoracic mode. The echocardiography data
contained the following variables: mean pressure gradient, peak pressure gradient, effective
orifice area (calculated by continuity equation), effective orifice index (effective orifice area
divided by BSA), and performance index (EOA / in vitro EOA).
|
| Follow-up Visits and Length of Follow-up |
Annual postoperative evaluations are performed on all patients of both cohorts, by the investigator. Types of follow-up methods used are office visit and telephone follow-up performed by the investigator. If the patient was seen at his/her primary care physician's office, medical records were requested by the investigator to collect data for the study.
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Three-hundred twenty-one (321) subjects were enrolled.
|
| Actual Number of Sites Enrolled |
Six (6) study sites were enrolled.
|
| Patient Follow-up Rate |
At 5-years there was a 67% follow-up rate.
|
| Final Safety Findings |
At 1 year, freedom from valve-related re-operations with explantation was 99.67%. At 5-years, the freedom from all reoperations with explants is 99.0% ± 0.7%., and at18-years, the freedom from all (valve-related) reoperations with explant is 78.5 ± 10.3%.
|
| Final Effect Findings |
NYHA Functional Class
1-year interval: preoperative and postoperative NYHA data were available for 194 patients. Of these patients, 87.6% showed improvement, 10.3% showed no change and 2.1% worsened in their NYHA functional class
4- to 5-year interval: data were available for 196 patients. Of these patients, 87.2% improved, 11.2% showed no change, and 1.6% worsened.
10- to 11-year interval: data were available for 91 patients. Of these patients, 87.9% improved, 9.9% were the same, and 2.4% worsened.
14- to 15-year interval: data were available for 54 patients. Of these patients, 83.3% improved, 13.0% were the same as their preoperative status and 3.7% worsened.
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| Study Strengths & Weaknesses |
The losses to follow-up are minimal and at least 67% of participants have been contacted at each time point up to 5 years. This rate is acceptable given the age and comorbidities of the population. Although the study protocol states the length of follow-up is 5-years, there are study participants that have been followed for much longer.
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| Recommendations for Labeling Changes |
Updated labeling requested from the sponsor should reflect the post-approval study safety and effectiveness data for the SAV valve. The post-approval study data should be presented separately from the original PMA data that reflect the data upon which the PMA application approval was based.
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