Back to resultsCENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
Primary Purpose
Aortic Valve Disease
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Sponsored by
About this trial
This is an interventional treatment trial for Aortic Valve Disease focused on measuring Transcatheter Aortic Valve Replacement, Aortic Stenosis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- The Prince Charles Hospital
- Royal Adelaide Hospital
- Epworth Healthcare
- Rigshospitalet
- Institut Hospitalier Jacques Cartier
- CHU Pontchaillou
- Clinique Pasteur
- Klinikum Augsburg
- Segeberger Kliniken GmbH
- Charité - Universitaetsmedizin Berlin
- Herzzentrum Universitaet Bonn
- Asklepios Klinik St Georg
- Universitaetsklinikum Hamburg-Eppendorf
- Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH
- Herzzentrum Leipzig GmbH
- Universitaetsklinikum Muenster
- Deutsches Herzzentrum Muenchen
- LMU - Klinikum der Universitaet Muenchen
- Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
- Ospedale San Raffaele s.r.l.
- Azienda Ospedaliero-Universitaria Pisana
- Academisch Medisch Centrum (AMC)
- Erasmus University Medical Center Rotterdam
- Universitair Medical Center (UMC) Utrecht
- Auckland City Hospital
- Inselspital Bern
- Royal Victoria Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single-arm
Arm Description
Outcomes
Primary Outcome Measures
All-cause mortality rate
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02458560
First Posted
May 28, 2015
Last Updated
October 8, 2021
Sponsor
Edwards Lifesciences
Collaborators
Medstar Health Research Institute, European Cardiovascular Research Center, University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT02458560
Brief Title
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
Official Title
Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
August 22, 2016 (Actual)
Study Completion Date
August 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
Collaborators
Medstar Health Research Institute, European Cardiovascular Research Center, University of British Columbia
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease
Keywords
Transcatheter Aortic Valve Replacement, Aortic Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
203 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single-arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Other Intervention Name(s)
TAVR, TAVI
Intervention Description
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).
Primary Outcome Measure Information:
Title
All-cause mortality rate
Time Frame
30 days post-index procedure
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Windecker, MD
Organizational Affiliation
Inselspital Bern (Switzerland)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prof. Hermann Reichenspurner, MD
Organizational Affiliation
University Heart Center Hamburg (Germany)
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Epworth Healthcare
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Institut Hospitalier Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Facility Name
CHU Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31300
Country
France
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Charité - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Herzzentrum Universitaet Bonn
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Facility Name
Asklepios Klinik St Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Staedtisches Klinikum Karlsruhe GmbH & Helios Herzchirurgie Karlsruhe GmbH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Herzzentrum Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04289
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
LMU - Klinikum der Universitaet Muenchen
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Ospedale Ferrarotto - Azienda Ospedaliero Universitaria di Catania
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Ospedale San Raffaele s.r.l.
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Academisch Medisch Centrum (AMC)
City
Amsterdam
ZIP/Postal Code
1105
Country
Netherlands
Facility Name
Erasmus University Medical Center Rotterdam
City
Rotterdam
ZIP/Postal Code
3015
Country
Netherlands
Facility Name
Universitair Medical Center (UMC) Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Facility Name
Auckland City Hospital
City
Grafton
State/Province
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30947942
Citation
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.
Results Reference
derived
PubMed Identifier
29268926
Citation
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.
Results Reference
derived
Learn more about this trial
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
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