Overview

This trial is active, not recruiting.

Condition aortic valve disease
Treatment edwards centera self-expanding transcatheter heart valve
Sponsor Edwards Lifesciences
Collaborator Medstar Health Research Institute
Start date February 2013
End date October 2013
Trial size 34 participants
Trial identifier NCT01808274, 2012-03

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
with CENTERA self-expanding valve
edwards centera self-expanding transcatheter heart valve TAVR
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 Outcomes

Measure
All-cause mortality rate
time frame: 30 days post-index procedure

Secondary Outcomes

Measure
device success
time frame: 30 days
device success
time frame: 1 year

Eligibility Criteria

All participants of any age.

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).

Additional Information

Official title Safety and Performance Study of the Edwards CENTERA Self-Expanding Transcatheter Heart Valve
Principal investigator Prof. Windecker, MD
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
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.