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 SAPIEN 3 Transcatheter Heart Valve (S3 THV) and the Edwards Commander and Certitude Delivery Systems in patients with symptomatic, severe aortic stenosis who are indicated for aortic valve replacement.
Detailed description
This is a non-randomized, prospective, multicenter safety and device success study. Two hundred fifty (250) patients are planned to be enrolled at up to 20 participating investigational centers in Europe and Canada. Patient participation will last for a minimum of 5 years. Patients will be assessed at the following intervals: baseline, hospital discharge, 30 days, 1 year and annually thereafter for a minimum of 5 years.
Interventions
The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).
Sponsors
Edwards Lifesciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Severe symptomatic calcific aortic valve stenosis with: 1. High surgical risk: STS Score ≥ 8 or EuroSCORE ≥ 15 (first 50 patients), 2. High to Intermediate surgical risk: STS Score ≥ 4 or EuroSCORE ≥ 10 (patients 51 to 150). 3. Intermediate surgical risk: STS Score 4 to 8 or Logistic EuroSCORE 10 to 15 (subsequent patients); except for 20mm valve implants (STS Score \> 4 or EuroSCORE ≥ 10). 2. Age ≥ 75 years 3. NYHA ≥ II 4. Heart team (including examining cardiac surgeon) agrees on eligibility including assessment that TAVR is appropriate. 5. Study patient has provided written informed consent to comply with all of the study procedures and follow-up visits.
Exclusion criteria
1. Non-calcified aortic valve 2. Acute myocardial infarction ≤ 30 days before the intended treatment 3. Untreated clinically significant coronary artery disease requiring revascularization. 4. Aortic valve is a congenital unicuspid or congenital bicuspid valve. 5. Mixed aortic valve disease (with predominant aortic regurgitation) 6. Preexisting bioprosthetic valve or ring in any position 7. For Intermediate Risk patients enrolled under inclusion criterion 1.c) patients with untreated pre-existing conduction disturbances (AV Block and Bundle Branch Block).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality rate | 30 days post-index procedure | NAP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| safety endpoints(VARC II) | Discharge or 72 hours (whichever is longer), 30 days, 1 and 5 years post-index procedure. | safety endpoints composite of mortality, and major complications including THV-related dysfunction major bleeds MI new conduction abnormality new onset of AF time-related valve safety composite of valve structural deterioration |
Countries
Canada, France, Germany, Italy, United Kingdom
Outcome results
None listed