BASELINE Trial
Protocol Description
This study compares a balloon expandable vs. self expanding transcatheter valve for degenerated bioprosthesis is an international multi-centered randomized study with 1:1 randomization to TAVI with SAPIEN-3/ULTRA or Evolute R/Pro. Enrollment duration is 18 months, follow up is 12 months. The study is embedded in clinical practice in which both THV platforms are routinely used.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 65 years
- Failing surgical aortic bioprosthesis requiring valve replacement and eligible for transfemoral TAVI with balloon expandable or self-expanding platform per heart team consensus based on multi-modality imaging assessment (including echocardiography and multidetector CT).
- Written informed consent
Exclusion Criteria
- Not eligible for Transfemoral TAVI with SAPIEN-3 / Ultra and Evolut R/Pro
- Multi-valve defects requiring intervention
- Clinically unstable and/or inotropic/vasopressor /mechanical support.
- Known mural thrombus in the left ventricle
- Presence of a mechanical aortic valve
- History of recent (within 1 month) stroke or TIA
Principal Investigator
Dr. Jason Foerst is a structural interventional cardiologist with over 20 years of clinical and research experience. He is the program director of Carilion Clinic's Structural Heart Disease fellowship. Dr. Foerst is board certified by The American Board of Internal Medicine and certified in interventional cardiology. He completed his internship, residency and fellowship at the Dartmouth-Hitchcock/Mary Hitchcock Memorial Hospital.
