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

NCT02458560 | Completed DMC FDA Device

• 1 other identifier: 2014-03
• Study Type: interventional
• Target: 203
• Locations: 9 countries
• Sites: 27

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.

Conditions

Aortic Valve Disease

Keywords

Transcatheter Aortic Valve Replacement; Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• All-cause mortality rate

  30 days post-index procedure

Secondary Outcomes (1)

• 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

Study Arms (1)

single-arm

EXPERIMENTAL

Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve

Interventions

Edwards CENTERA Self-Expanding Transcatheter Heart Valve DEVICE

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).

Also known as: TAVR, TAVI

single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Edwards Lifesciences: lead
• Medstar Health Research Institute: collaborator
• European Cardiovascular Research Center: collaborator
• University of British Columbia: collaborator

Study Sites (27)

The Prince Charles Hospital

Brisbane, Queensland, 4032, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Epworth Healthcare

Melbourne, Victoria, 3121, Australia

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Institut Hospitalier Jacques Cartier

Massy, 91300, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Clinique Pasteur

Toulouse, 31300, France

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Charité - Universitaetsmedizin Berlin

Berlin, 10117, Germany

Location

Herzzentrum Universitaet Bonn

Bonn, 53105, Germany

Location

Asklepios Klinik St Georg

Hamburg, 20099, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH

Karlsruhe, 76133, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

LMU - Klinikum der Universitaet Muenchen

Munich, 81377, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania

Catania, 95124, Italy

Location

Ospedale San Raffaele s.r.l.

Milan, 20132, Italy

Location

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56124, Italy

Location

Academisch Medisch Centrum (AMC)

Amsterdam, 1105, Netherlands

Location

Erasmus University Medical Center Rotterdam

Rotterdam, 3015, Netherlands

Location

Universitair Medical Center (UMC) Utrecht

Utrecht, 3584, Netherlands

Location

Auckland City Hospital

Grafton, Auckland, 1023, New Zealand

Location

Inselspital Bern

Bern, 3010, Switzerland

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 30947942 DERIVED

• 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.

  PMID: 29268926 DERIVED

MeSH Terms

Conditions

Aortic Valve Disease; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Prof. Windecker, MD

  Inselspital Bern (Switzerland)

  PRINCIPAL INVESTIGATOR

• Prof. Hermann Reichenspurner, MD

  University Heart Center Hamburg (Germany)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2015
• First Posted: June 1, 2015
• Study Start: March 1, 2015
• Primary Completion: August 22, 2016
• Study Completion: August 13, 2021
• Last Updated: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); DK (1); NZ (1); DE (11); CH (1); FR (3); GB (1); IT (3); NL (3)