This is a Prospective, multi‐center, international, randomized controlled, post‐market trial. To enroll subjects with symptomatic heart disease due to severe native calcific aortic stenosis and a small annulus appropriate for transcatheter heart valvereplacement therapy. The purpose of this trial is to generate clinical evidence on valve safety and performance of self‐expanding (SE) versus balloon‐expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis. Devices used in this trial must be commercially approved by the local regulatory agencies in the geography they are used. The devices will be used within the localcommercially approved indication in the geographies in which each device is approved. Subjects will be randomized on a 1:1 basis to receive transcatheter aortic valve replacement (TAVR) with either a Medtronic SE or an Edwards BE TAV. Randomization will be stratified by site and sex. Approximately 700 treated subjects at approximately 90 sites in Canada, EMEA and the United States.
Inclusion Criteria
- Symptomatic subjects with predicted risk of operative mortality < 15% at 30‐ days per multidisciplinary local heart team assessment.
- Severe aortic stenosis stenosis, defined as: Aortic valve area ≤1.0 cm2 (or aortic valve area index of ≤0.6 cm2/m2), OR mean gradient ≥40 mmHg, OR maximal aortic valve velocity ≥4.0 m/sec by transthoracic echocardiography at rest.
- Subject’s anatomy is suitable for TAVR via transfemoral vessel access.
Exclusion Criteria
- Estimated life expectancy of less than 2 years
- Multivessel coronary artery disease with a Syntax score >32 and/or unprotected left main coronary artery.
- Participating in another trial that may influence the outcome of this trial
Study Requirements
All randomized and treated subjects will undergo a 5‐year follow‐up period. For each subject, data will be collected at pre‐ and post‐procedure, at discharge, at 30 days and once a year until the 5‐year follow‐up is completed.
Main collected data will be:
- Baseline subject demographics, medical history, anatomical eligibility, MDCT, and Society of Thoracic Surgeons‐Predicted Risk or Mortality (STSPROM) score at Screening
- Procedural/discharge evaluations
- Clinical assessment at Screening, Baseline, Discharge, 30‐day, 12‐month, 2‐year, 3‐year, 4‐year and 5‐year follow‐up visitsTransthoracic echo at Screening, Discharge, 30‐day, 12‐month, 2‐year, 3‐year, 4‐year and 5‐year follow‐up visits 12‐lead ECG at Pre‐ and post‐procedure, Discharge, 30‐day and 12‐ monthfollow‐up visits
- NYHA at Screening, Baseline, Discharge, 30‐day, 12‐month, 2‐year, 3‐year, 4‐year and 5‐year follow‐up visits
- Quality of Life assessments at Baseline, 30‐day, 12‐month, 2‐ year, 3‐year, 4‐year and 5‐year follow‐up visits
- 6‐minute walk test at Baseline, 30‐day, 12‐month, 2‐year, 3‐year, 4‐year and 5‐year follow‐up visits
