Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
This trial is active, not recruiting.
|Condition||aortic valve disease|
|Treatment||edwards centera self-expanding transcatheter heart valve|
|Collaborator||Medstar Research Institute|
|Start date||February 2013|
|End date||December 2014|
|Trial size||34 participants|
|Trial identifier||NCT01808274, 2012-03|
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 indicated for aortic valve replacement.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Bonn, Germany||Herzzentrum Universitaet Bonn||no longer recruiting|
|Hamburg, Germany||Asklepios Klinik St Georg Hamburg||no longer recruiting|
|Leipzig, Germany||Heart Center Leipzig||no longer recruiting|
|Bern, Switzerland||Inselspital Bern||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
All-cause mortality rate
time frame: 30 days post-index procedure
device success (VARC II) safety endpoints (VARC II) echocardiography endpoints (VARC II)
time frame: Discharge or 72 hours (whichever is longer), 30 days, 6 months, 1and 5 year post-index procedure.
Male or female participants of any age.
Inclusion Criteria: 1. High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15. 2. NYHA ≥ II 3. AVA< 1cm2 and mean gradient > 40mmHg 4. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate 5. Study patient is an adult of legal consent age 6. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits Exclusion Criteria: 1. Acute myocardial infarction ≤ 30 days before the intended treatment 2. Untreated clinically significant coronary artery disease requiring revascularization. 3. Aortic valve is a congenital unicuspid or congenital bicuspid valve. 4. Mixed aortic valve disease (with predominant aortic regurgitation) 5. Preexisting bioprosthetic valve or ring in any position 6. Leukopenia, anemia, thrombocytopenia 7. Non-valvular hypertrophic cardiomyopathy with or without obstruction 8. Severe ventricular dysfunction with LVEF < 20% 9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation 10. Active upper GI bleeding within 30 days prior to procedure 11. Known contraindication or hypersensitivity to all anticoagulation regimens, or inability to be anticoagulated for the study procedure 12. Native aortic annulus size < 18 mm or > 27 mm as measured by CT 13. Clinically (by neurologist) or neuroimaging confirmed stroke or TIA within 180 days of the procedure 14. Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy at the time of screening 15. Estimated life expectancy < 24 months 16. Expectation that patient will not improve despite treatment of aortic stenosis 17. Currently participating in an investigational drug or another device study 18. Active bacterial endocarditis within 180 days of procedure 19. Access vessel characteristics that would preclude safe placement of a 16F sheath, which may include any of the following: severe obstructive calcification, severe tortuosity 20. Known hypersensitivity to nitinol (nickel or titanium) 21. PCI within one month (30 days) prior to the TAVI procedure 22. Emergency procedures within one month (30 days) prior to the TAVI procedure. 23. Severe mitral insufficiency
|Official title||Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve|
|Principal investigator||Prof. Windecker, MD|
|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 last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, discharge, 30 days, 6 months, 1 year and annually thereafter through 5 years|
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