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NCT02458560 Clinical Trial

CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Aortic Valve Disease Clinical Trial

Official title:
Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02458560
Other study ID # 2014-03
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2015
Est. completion date August 13, 2021

Study information
Verified date October 2021
Source Edwards Lifesciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 203
Est. completion date August 13, 2021
Est. primary completion date August 22, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. Study patient is an adult of legal consent age. 5. 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).

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Edwards CENTERA Self-Expanding Transcatheter Heart Valve
The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).

Locations
Country Name City State
Australia Royal Adelaide Hospital Adelaide South Australia
Australia The Prince Charles Hospital Brisbane Queensland
Australia Epworth Healthcare Melbourne Victoria
Denmark Rigshospitalet Copenhagen
France Institut Hospitalier Jacques Cartier Massy
France CHU Pontchaillou Rennes
France Clinique Pasteur Toulouse
Germany Klinikum Augsburg Augsburg
Germany Segeberger Kliniken GmbH Bad Segeberg
Germany Charité - Universitaetsmedizin Berlin Berlin
Germany Herzzentrum Universitaet Bonn Bonn
Germany Asklepios Klinik St Georg Hamburg
Germany Universitaetsklinikum Hamburg-Eppendorf Hamburg
Germany Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH Karlsruhe
Germany Herzzentrum Leipzig GmbH Leipzig
Germany Universitaetsklinikum Muenster Muenster
Germany Deutsches Herzzentrum Muenchen Munich
Germany LMU - Klinikum der Universitaet Muenchen Munich
Italy Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania Catania
Italy Ospedale San Raffaele s.r.l. Milan
Italy Azienda Ospedaliero-Universitaria Pisana Pisa
Netherlands Academisch Medisch Centrum (AMC) Amsterdam
Netherlands Erasmus University Medical Center Rotterdam Rotterdam
Netherlands Universitair Medical Center (UMC) Utrecht Utrecht
New Zealand Auckland City Hospital Grafton Auckland
Switzerland Inselspital Bern Bern
United Kingdom Royal Victoria Hospital Belfast

Sponsors (4)
Lead Sponsor Collaborator
Edwards Lifesciences European Cardiovascular Research Center, Medstar Health Research Institute, University of British Columbia

Countries where clinical trial is conducted

Australia,  Denmark,  France,  Germany,  Italy,  Netherlands,  New Zealand,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary All-cause mortality rate 30 days post-index procedure
Secondary 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
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