Status:
COMPLETED
Safety and Performance Study of the Edwards SAPIEN 3 Transcatheter Heart Valve/ The SAPIEN 3 Study
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
75+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and device success of the Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients wit...
Detailed Description
This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Eur...
Eligibility Criteria
Inclusion
- Severe symptomatic calcific aortic valve stenosis with:
- High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients),
- High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150).
- Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score \> 4 or EuroSCORE ≥ 10).
- Age ≥ 75 years
- NYHA ≥ II
- Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Exclusion
- Non-calcified aortic valve
- Acute myocardial infarction ≤ 30 days before the intended treatment
- Untreated clinically significant coronary artery disease requiring revascularization.
- Aortic valve is a congenital unicuspid or congenital bicuspid valve.
- Mixed aortic valve disease (with predominant aortic regurgitation)
- Preexisting bioprosthetic valve or ring in any position
- For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2019
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT01808287
Start Date
January 1 2013
End Date
December 17 2019
Last Update
April 1 2020
Active Locations (17)
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1
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1 Y6
2
Laval, Institut universitaire de cardiologie et de pneumologie de Quebec
Laval, Quebec, Canada, G1V4G5
3
Massy, Institut Jacques Cartier
Massy, France, 91300
4
Paris, Hopital Bichat
Paris, France, 75018