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

NCT ID: NCT01808274

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-01
• Study Completion Date: 2018-08-23

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

Conditions

Aortic Valve Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAVR

with CENTERA self-expanding valve

Group Type: EXPERIMENTAL

Edwards CENTERA Self-Expanding Transcatheter Heart Valve

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

TAVR; TAVI

Eligibility 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).

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

European Cardiovascular Research Center

NETWORK

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: collaborator

Edwards Lifesciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Windecker, MD

Role: PRINCIPAL_INVESTIGATOR

Inselspital Bern (Switzerland)

Prof. Mohr, MD

Role: PRINCIPAL_INVESTIGATOR

Leipzig, Rhön Herzentrum (Germany)

Locations

Herzzentrum Universitaet Bonn

Bonn, , Germany

Asklepios Klinik St Georg Hamburg

Hamburg, , Germany

Heart Center Leipzig

Leipzig, , Germany

Inselspital Bern

Bern, , Switzerland

Countries

Germany; Switzerland

Other Identifiers

2012-03

Identifier Type: -

Identifier Source: org_study_id