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 symptomatic adult patients with severe aortic stenosis.
Detailed 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.
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
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality rate | 30 days post-index procedure |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 30 days |
Countries
Australia, Denmark, France, Germany, Italy, Netherlands, New Zealand, Switzerland, United Kingdom
Outcome results
None listed