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

Edwards Lifesciences34 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Disease

Interventions

Edwards CENTERA Self-Expanding Transcatheter Heart ValveDEVICE

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).

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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).

Locations (4)

Herzzentrum Universitaet Bonn

Bonn, Germany

Asklepios Klinik St Georg Hamburg

Hamburg, Germany

Heart Center Leipzig

Leipzig, Germany

Inselspital Bern

Bern, Switzerland

Outcomes

Primary Outcomes

All-cause mortality rate

NAP

Time frame: 30 days post-index procedure

Secondary Outcomes

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).

Time frame: 30 days

device success

Time frame: 1 year

Data from ClinicalTrials.gov

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