Status:
COMPLETED
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Lead Sponsor:
Edwards Lifesciences
Collaborating Sponsors:
Medstar Health Research Institute
European Cardiovascular Research Center
Conditions:
Aortic Valve Disease
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe aortic stenosis who are indicate...
Detailed Description
This is a non-randomized, prospective, multi-center safety and device success study. 34 patients have been enrolled at 4 participating investigational centers in Europe. Patient participation will las...
Eligibility Criteria
Inclusion
- High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
- NYHA ≥ II.
- Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
- Study patient is an adult of legal consent age.
- Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Exclusion
- 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).
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2018
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01808274
Start Date
February 1 2013
End Date
August 23 2018
Last Update
November 20 2018
Active Locations (4)
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1
Herzzentrum Universitaet Bonn
Bonn, Germany, 53127
2
Asklepios Klinik St Georg Hamburg
Hamburg, Germany, 20099
3
Heart Center Leipzig
Leipzig, Germany, 042 89
4
Inselspital Bern
Bern, Switzerland, 3010