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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02458560
Recruitment Status : Active, not recruiting
First Posted : June 1, 2015
Last Update Posted : September 12, 2019
Sponsor:
Collaborators:
Medstar Health Research Institute
European Cardiovascular Research Center
University of British Columbia
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
Actual Study Start Date : March 2015
Actual Primary Completion Date : August 22, 2016
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: single-arm 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).
Other Names:
  • TAVR
  • TAVI




Primary Outcome Measures :
  1. All-cause mortality rate [ Time Frame: 30 days post-index procedure ]
    NAP


Secondary Outcome Measures :
  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. [ Time Frame: 30 days ]
    NAP



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02458560


Locations
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Australia, Queensland
The Prince Charles Hospital
Brisbane, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Epworth Healthcare
Melbourne, Victoria, Australia, 3121
Denmark
Rigshospitalet
Copenhagen, Denmark, 2100
France
Institut Hospitalier Jacques Cartier
Massy, France, 91300
CHU Pontchaillou
Rennes, France, 35033
Clinique Pasteur
Toulouse, France, 31300
Germany
Klinikum Augsburg
Augsburg, Germany, 86156
Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Charité - Universitaetsmedizin Berlin
Berlin, Germany, 10117
Herzzentrum Universitaet Bonn
Bonn, Germany, 53105
Asklepios Klinik St Georg
Hamburg, Germany, 20099
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH
Karlsruhe, Germany, 76133
Herzzentrum Leipzig GmbH
Leipzig, Germany, 04289
Universitaetsklinikum Muenster
Muenster, Germany, 48149
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
LMU - Klinikum der Universitaet Muenchen
Munich, Germany, 81377
Italy
Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
Catania, Italy, 95124
Ospedale San Raffaele s.r.l.
Milan, Italy, 20132
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56124
Netherlands
Academisch Medisch Centrum (AMC)
Amsterdam, Netherlands, 1105
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands, 3015
Universitair Medical Center (UMC) Utrecht
Utrecht, Netherlands, 3584
New Zealand
Auckland City Hospital
Grafton, Auckland, New Zealand, 1023
Switzerland
Inselspital Bern
Bern, Switzerland, 3010
United Kingdom
Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA
Sponsors and Collaborators
Edwards Lifesciences
Medstar Health Research Institute
European Cardiovascular Research Center
University of British Columbia
Investigators
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Principal Investigator: Prof. Windecker, MD Inselspital Bern (Switzerland)
Principal Investigator: Prof. Hermann Reichenspurner, MD University Heart Center Hamburg (Germany)