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

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
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease focused on measuring Transcatheter Aortic Valve Replacement, Aortic Stenosis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Herzzentrum Universitaet Bonn
  • Asklepios Klinik St Georg Hamburg
  • Heart Center Leipzig
  • Inselspital Bern

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAVR

Arm Description

with CENTERA self-expanding valve

Outcomes

Primary Outcome Measures

All-cause mortality rate
NAP

Secondary Outcome Measures

device success
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).
device success
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).

Full Information

First Posted
March 7, 2013
Last Updated
November 16, 2018
Sponsor
Edwards Lifesciences
Collaborators
Medstar Health Research Institute, European Cardiovascular Research Center, University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01808274
Brief Title
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Acronym
CENTERA-1
Official Title
Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
September 17, 2013 (Actual)
Study Completion Date
August 23, 2018 (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

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 patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
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

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
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAVR
Arm Type
Experimental
Arm Description
with CENTERA self-expanding valve
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
Description
NAP
Time Frame
30 days post-index procedure
Secondary Outcome Measure Information:
Title
device success
Description
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).
Time Frame
30 days
Title
device success
Description
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).
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High surgical risk: STS Score ≥ 8,EuroSCORE ≥ 15. NYHA ≥ II. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate. 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. Mohr, MD
Organizational Affiliation
Leipzig, Rhön Herzentrum (Germany)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herzzentrum Universitaet Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Asklepios Klinik St Georg Hamburg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Heart Center Leipzig
City
Leipzig
ZIP/Postal Code
042 89
Country
Germany
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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