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

Not Applicable

Completed

• Conditions: Aortic Valve Disease
• Interventions: Device: Edwards CENTERA Self-Expanding Transcatheter Heart Valve

• Registration Number: NCT01808274
• Lead Sponsor: 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 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

Study Timeline

• Study Start: 2013-02-01
• Study First Submitted: 2013-03-07
• Study First Submitted QC: 2013-03-07
• Study First Posted: 2013-03-11
• Primary Completion: 2013-09-17
• Study Completion: 2018-08-23
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-16
• Last Update Posted: 2018-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVR	Edwards CENTERA Self-Expanding Transcatheter Heart Valve	with CENTERA self-expanding valve

Primary Outcome Measures

Name	Time	Method
All-cause mortality rate	30 days post-index procedure	NAP

Secondary Outcome Measures

Name	Time	Method
device success	1 year	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).

Trial Locations

Locations (4)

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

Inselspital Bern; 🇨🇭 Bern, Switzerland

Asklepios Klinik St Georg Hamburg; 🇩🇪 Hamburg, Germany

Herzzentrum Universitaet Bonn; 🇩🇪 Bonn, Germany