Aortic Valve Disease
Conditions
Keywords
Transcatheter Aortic Valve Replacement, Aortic Stenosis
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
Interventions
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).
Sponsors
Medstar Health Research Institute
European Cardiovascular Research Center
University of British Columbia
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate | 30 days post-index procedure | NAP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| device success | 30 days | 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). |
Countries
Germany, Switzerland
Outcome results
None listed