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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100041 / PAS002 |
| Date Original Protocol Accepted |
11/02/2011
|
| Date Current Protocol Accepted |
08/28/2014
|
| Study Name |
Newly Enrolled Study
|
| Device Name |
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Design: a non-randomized, retrospective, consecutively enrolled STS/ACC TVT Registry of all patients undergoing SAPIEN transcatheter heart valve replacement therapy.
|
| Study Population |
Patients must meet the fundamental enrollment criteria of severe, symptomatic, calcific aortic stenosis with quantifiable and documented source records. Upon meeting these eligibility criteria, the heart team shall then determine the patients risk for operative morbidity and mortality. Details of eligibility including contraindications are provided in the product Instructions for Use which are included with each SAPIEN THV and delivery system.
No comparator group.
|
| Sample Size |
A total of 5000 subjects combined for P110021 & P100041 patients enrolled into the STS/ACC TVT Registry in all US sites.
|
| Key Study Endpoints |
Primary Safety Endpoints:
The primary safety endpoint is the clinical event of stroke at 30 days, and again at 1 year.
2. Additional Safety Endpoints:
Additional safety endpoints will be evaluated at 30 days and one
year:
VARC composite safety:
o all-cause mortality stroke;
o life-threatening (or disabling) bleeding
o acute kidney injury - Stage 3 (including renal replacement therapy)
o peri-procedural MI
o repeat procedure for valve-related dysfunction (surgical or interventional
therapy)
Major vascular complications
Stroke (as defined in the STS/ACC TVT Registry)
3. Additional Effectiveness Endpoints:
Additional effectiveness endpoints will be evaluated at 30 days and one year:
Total days alive and out of hospital (from date of implant)
Clinical improvement per NYHA Class (from baseline)
Mean ICU and total index procedure hospital length of stay
4. Learning Curve Assessment:
The learning curve assessment will be made by analyzing the composite safety outcome according to the VARC guidelines. Additional evaluation will be performed for stroke and vascular complication. The rationale for assessment the composite at 30 day is that it is reflective of acute procedure outcomes, device performance and important potential procedure complications addressed in the Edwards SAPIEN THV Training program
|
| Follow-up Visits and Length of Follow-up |
5 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
4994
|
| Actual Number of Sites Enrolled |
209
|
| Patient Follow-up Rate |
year 1: >80%; year 2-5: <80%
|
| Final Safety Findings |
All-cause mortality at 5 years: 64.2%
Stroke at 5 years: 13.9%
TIA at 5 years: 4.2%
Aortic Valve Re-intervention at 5 years: 3.1%
Re-intervention on Unspecified Valve at 5 years: 0.5%
New Requirement for Dialysis at 5 years: 4.8%
|
| Final Effect Findings |
Survival at 5 years: 35.8%
|
| Study Strengths & Weaknesses |
Strength: Large number of real-world patients enrolled in a relatively short period of time (about 10 months).
Weakness: Drop in follow-up rate post 1 year due to the inherent limitations in linking the TVT Registry with the CMS claims database.
|
| Recommendations for Labeling Changes |
No. Device has been discontinued due to obsolescence.
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