Safety and Performance Study of the Edwards CENTERA-EU 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 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|
|Brisbane, Australia||The Prince Charles Hospital||no longer recruiting|
|Adelaide, Australia||Royal Adelaide Hospital||no longer recruiting|
|Melbourne, Australia||Epworth Healthcare||no longer recruiting|
|Copenhagen, Denmark||Rigshospitalet||no longer recruiting|
|Massy, France||Institut Hospitalier Jacques Cartier||no longer recruiting|
|Rennes, France||CHU Pontchaillou||no longer recruiting|
|Toulouse, France||Clinique Pasteur||no longer recruiting|
|Augsburg, Germany||Klinikum Augsburg||no longer recruiting|
|Bad Segeberg, Germany||Segeberger Kliniken GmbH||no longer recruiting|
|Berlin, Germany||Charité - Universitaetsmedizin Berlin||no longer recruiting|
|Bonn, Germany||Herzzentrum Universitaet Bonn||no longer recruiting|
|Hamburg, Germany||Asklepios Klinik St Georg||no longer recruiting|
|Hamburg, Germany||Universitaetsklinikum Hamburg-Eppendorf||no longer recruiting|
|Karlsruhe, Germany||Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH||no longer recruiting|
|Leipzig, Germany||Herzzentrum Leipzig GmbH||no longer recruiting|
|Muenster, Germany||Universitaetsklinikum Muenster||no longer recruiting|
|Munich, Germany||Deutsches Herzzentrum Muenchen||no longer recruiting|
|Munich, Germany||LMU - Klinikum der Universitaet Muenchen||no longer recruiting|
|Catania, Italy||Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania||no longer recruiting|
|Milan, Italy||Ospedale San Raffaele s.r.l.||no longer recruiting|
|Pisa, Italy||Azienda Ospedaliero-Universitaria Pisana||no longer recruiting|
|Amsterdam, Netherlands||Academisch Medisch Centrum (AMC)||no longer recruiting|
|Rotterdam, Netherlands||Erasmus University Medical Center Rotterdam||no longer recruiting|
|Utrecht, Netherlands||Universitair Medical Center (UMC) Utrecht||no longer recruiting|
|Grafton, New Zealand||Auckland City Hospital||no longer recruiting|
|Bern, Switzerland||Inselspital Bern||no longer recruiting|
|Belfast, United Kingdom||Royal Victoria Hospital||no longer recruiting|
|Intervention model||single group assignment|
All-cause mortality rate
time frame: 30 days post-index procedure
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
All participants at least 18 years old.
- 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).
|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.|
Call for more information