This trial is active, not recruiting.

Condition aortic valve disease
Treatment edwards centera self-expanding transcatheter heart valve
Sponsor Edwards Lifesciences
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

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

All-cause mortality rate
time frame: 30 days post-index procedure

Secondary Outcomes

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.

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.