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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 : October 5, 2020
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)
Actual Enrollment : 203 participants
Allocation: N/A
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 ]

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 ]


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
Show Show 27 study locations
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)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT02458560    
Other Study ID Numbers: 2014-03
First Posted: June 1, 2015    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Edwards Lifesciences:
Transcatheter Aortic Valve Replacement
Aortic Stenosis
Additional relevant MeSH terms:
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Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases