CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
NCT ID: NCT02458560
Last Updated: 2021-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
203 participants
INTERVENTIONAL
2015-03-31
2021-08-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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single-arm
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Medstar Health Research Institute
OTHER
European Cardiovascular Research Center
NETWORK
University of British Columbia
OTHER
Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Windecker, MD
Role: PRINCIPAL_INVESTIGATOR
Inselspital Bern (Switzerland)
Prof. Hermann Reichenspurner, MD
Role: PRINCIPAL_INVESTIGATOR
University Heart Center Hamburg (Germany)
Locations
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Inselspital Bern
Bern, , Switzerland
Royal Victoria Hospital
Belfast, , United Kingdom
The Prince Charles Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Epworth Healthcare
Melbourne, Victoria, Australia
Rigshospitalet
Copenhagen, , Denmark
Institut Hospitalier Jacques Cartier
Massy, , France
CHU Pontchaillou
Rennes, , France
Clinique Pasteur
Toulouse, , France
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
Deutsches Herzzentrum Muenchen
Munich, , Germany
LMU - Klinikum der Universitaet Muenchen
Munich, , Germany
Universitaetsklinikum Muenster
Münster, , Germany
Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
Catania, , Italy
Ospedale San Raffaele s.r.l.
Milan, , Italy
Azienda Ospedaliero-Universitaria Pisana
Pisa, , Italy
Academisch Medisch Centrum (AMC)
Amsterdam, , Netherlands
Erasmus University Medical Center Rotterdam
Rotterdam, , Netherlands
Universitair Medical Center (UMC) Utrecht
Utrecht, , Netherlands
Auckland City Hospital
Grafton, Auckland, New Zealand
Countries
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References
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Tchetche D, Windecker S, Kasel AM, Schaefer U, Worthley S, Linke A, Abdel-Wahab M, Le Breton H, Sondergaard L, Spence MS, Petronio S, Baumgartner H, Hovorka T, Blanke P, Reichenspurner H. 1-Year Outcomes of the CENTERA-EU Trial Assessing a Novel Self-Expanding Transcatheter Heart Valve. JACC Cardiovasc Interv. 2019 Apr 8;12(7):673-680. doi: 10.1016/j.jcin.2019.01.231.
Reichenspurner H, Schaefer A, Schafer U, Tchetche D, Linke A, Spence MS, Sondergaard L, LeBreton H, Schymik G, Abdel-Wahab M, Leipsic J, Walters DL, Worthley S, Kasel M, Windecker S. Self-Expanding Transcatheter Aortic Valve System for Symptomatic High-Risk Patients With Severe Aortic Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3127-3136. doi: 10.1016/j.jacc.2017.10.060.
Other Identifiers
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2014-03
Identifier Type: -
Identifier Source: org_study_id