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Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve (CENTERA-1)

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ClinicalTrials.gov Identifier: NCT01808274
Recruitment Status : Completed
First Posted : March 11, 2013
Last Update Posted : November 20, 2018
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 patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.

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. 34 patients have been enrolled at 4 participating investigational centers in Europe. 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)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Actual Study Start Date : February 1, 2013
Actual Primary Completion Date : September 17, 2013
Actual Study Completion Date : August 23, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAVR
with CENTERA self-expanding valve
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. device success [ Time Frame: 30 days ]

    Device success is defined as a composite of the following events:

    Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment).

    It is measured in % (favorable measures/total measures).


  2. device success [ Time Frame: 1 year ]

    Device success is defined as a composite of the following events:

    Factor 1: Absence of procedural mortality Factor 2: Correct positioning of a single prosthetic valve into the proper anatomical location Factor 3: Intended performance of the prosthetic heart valve (per the 30-day core lab echo assessment).

    It is measured in % (favorable measures/total measures).




Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15.
  2. NYHA ≥ II.
  3. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate.
  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): NCT01808274


Locations
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Germany
Herzzentrum Universitaet Bonn
Bonn, Germany, 53127
Asklepios Klinik St Georg Hamburg
Hamburg, Germany, 20099
Heart Center Leipzig
Leipzig, Germany, 042 89
Switzerland
Inselspital Bern
Bern, Switzerland, 3010
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. Mohr, MD Leipzig, Rhön Herzentrum (Germany)

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT01808274     History of Changes
Other Study ID Numbers: 2012-03
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Edwards Lifesciences:
Transcatheter Aortic Valve Replacement
Aortic Stenosis

Additional relevant MeSH terms:
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Heart Defects, Congenital
Heart Valve Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities