CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
- Conditions
- Aortic Valve Disease
- Interventions
- Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Registration Number
- NCT02458560
- Lead Sponsor
- Edwards Lifesciences
- 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 symptomatic adult patients with severe aortic stenosis.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate.
- High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40.
- NYHA ≥ II.
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description single-arm Edwards CENTERA Self-Expanding Transcatheter Heart Valve -
- Primary Outcome Measures
Name Time Method All-cause mortality rate 30 days post-index procedure
- Secondary Outcome Measures
Name Time Method 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. 30 days
Trial Locations
- Locations (27)
Rigshospitalet
🇩🇰Copenhagen, Denmark
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Segeberger Kliniken GmbH
🇩🇪Bad Segeberg, Germany
Epworth Healthcare
🇦🇺Melbourne, Victoria, Australia
Institut Hospitalier Jacques Cartier
🇫🇷Massy, France
Klinikum Augsburg
🇩🇪Augsburg, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Azienda Ospedaliero-Universitaria Pisana
🇮🇹Pisa, Italy
Universitaetsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
🇮🇹Catania, Italy
The Prince Charles Hospital
🇦🇺Brisbane, Queensland, Australia
Clinique Pasteur
🇫🇷Toulouse, France
CHU Pontchaillou
🇫🇷Rennes, France
Ospedale San Raffaele s.r.l.
🇮🇹Milan, Italy
Academisch Medisch Centrum (AMC)
🇳🇱Amsterdam, Netherlands
Inselspital Bern
🇨🇭Bern, Switzerland
Asklepios Klinik St Georg
🇩🇪Hamburg, Germany
Herzzentrum Universitaet Bonn
🇩🇪Bonn, Germany
Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH
🇩🇪Karlsruhe, Germany
Deutsches Herzzentrum Muenchen
🇩🇪Munich, Germany
LMU - Klinikum der Universitaet Muenchen
🇩🇪Munich, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Universitair Medical Center (UMC) Utrecht
🇳🇱Utrecht, Netherlands
Auckland City Hospital
🇳🇿Grafton, Auckland, New Zealand
Erasmus University Medical Center Rotterdam
🇳🇱Rotterdam, Netherlands
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Charité - Universitaetsmedizin Berlin
🇩🇪Berlin, Germany