This trial is active, not recruiting.

Condition aortic valve disease
Treatment edwards centera self-expanding transcatheter heart valve
Sponsor Edwards Lifesciences
Collaborator Medstar Health Research Institute
Start date March 2015
End date September 2016
Trial size 200 participants
Trial identifier NCT02458560, 2014-03


The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

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

Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure.
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate 2. High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40. 3. NYHA ≥ II 4. Severe symptomatic aortic stenosis requiring aortic valve replacement characterized by AVA < 1cm2 (or indexed AVA <0.6 cm2/m2) or • mean gradient > 40mmHg (or peak aortic jet velocity > 4.0m/sec) 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 or intraaortic mass, thrombus or vegetation 10. Active upper GI bleeding within 90 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 90 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 14F sheath, which may include any of the following: severe obstructive calcification, severe tortuosity 20. Known hypersensitivity to nitinol (nickel or titanium) or contrast media 21. PCI within one month (30 days) prior to the TAVI procedure 22. Emergency interventional/surgical 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-EU Self-Expanding Transcatheter Heart Valve
Principal investigator Prof. Windecker, MD
Description This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. 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 October 2016.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.