CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
|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 : Completed
First Posted : June 1, 2015
Last Update Posted : October 18, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Disease||Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Completion Date :||August 13, 2021|
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).
- All-cause mortality rate [ Time Frame: 30 days post-index procedure ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
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
|Principal Investigator:||Prof. Windecker, MD||Inselspital Bern (Switzerland)|
|Principal Investigator:||Prof. Hermann Reichenspurner, MD||University Heart Center Hamburg (Germany)|
|Responsible Party:||Edwards Lifesciences|
|Other Study ID Numbers:||
|First Posted:||June 1, 2015 Key Record Dates|
|Last Update Posted:||October 18, 2021|
|Last Verified:||October 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|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|
Transcatheter Aortic Valve Replacement
Aortic Valve Disease
Heart Valve Diseases