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 March 2015
End date September 2016
Trial size 200 participants
Trial identifier NCT02458560, 2014-03

Summary

The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.

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)
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
Safety composite of mortality, stroke, major vascular, complication, life-threatening bleeding, acute kidney injury coronary artery obstruction requiring intervention, and THV-related dysfunction requiring repeat procedure.
time frame: 30 days

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: 1. Heart team (including cardiac surgeon) agrees on eligibility including as-sessment that TAVI is appropriate. 2. High surgical risk: 8 ≤ STS Score ≤ 15 or 15 ≤ Logistic EuroSCORE I ≤ 40. 3. NYHA ≥ II. 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-EU Self-Expanding Transcatheter Heart Valve
Principal investigator Prof. Windecker, MD
Description This is a non-randomized, prospective, multi-center safety and device success study. Up to two hundred (200) patients are planned to be implanted at up to 35 participating investigational centers in Europe, Australia and New Zealand. 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.