BASELINE Trial v1.0
Research type
Research Study
Full title
BASELINE Trial: Balloon Expandable versus Self Expanding Transcatheter Valve for Degenerated Bioprosthesis
IRAS ID
294387
Contact name
Daniel James Blackman
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Approximately 80% of open-heart surgery to replace failing aortic valves is performed using a biological prosthesis. Durability of these bioprostheses varies based on many patient factors and in some patients the surgical bioprosthesis begins to fail after 8-10 years. Repeat open heart surgery for a degenerated aortic bioprosthesis is a relatively high-risk procedure with a reported procedural mortality of 4 – 9% and overall high morbidity. Transcatheter aortic valve implantation (TAVI) is a minimally invasive keyhole procedure (using the femoral artery) that has become the preferred treatment for failing native aortic valves and degenerated aortic bioprostheses in elderly patients. Studies have reported better short-term survival and less morbidity with TAVI compared to open-heart surgery for the treatment of degenerated aortic bioprosthesis. Balloon expandable and self-expanding heart valves are two different types of valves that can be used for TAVI in degenerated bioprostheses and each has specific advantages and disadvantages. The Sapien3 Ultra (balloon expandable) and Evolut R/Pro (self-expanding) are the 2 most commonly used valves in contemporary clinical practice for the treatment of degenerated surgical aortic bioprostheses. It is not known which type of valve provides better clinical outcomes for the treatment of degenerated surgical aortic bioprostheses. This study is an international multi-centre randomised trial that will compare the Sapien 3 Ultra and EVOLUT R/Pro valves for the treatment of degenerated surgical aortic valve prostheses. Patients aged ≥ 65 years, with degenerated surgical aortic bioprosthesis, who are found eligible for TAVI (using the femoral artery) by the local heart team will be randomised to receive a SAPIEN3 Ultra or Evolut R/Pro valve. Patients will be followed up at 1 month and 1 year, including with a heart scan, to determine whether outcomes, including valve function, are better with one valve than the other
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0027
Date of REC Opinion
23 Mar 2022
REC opinion
Further Information Favourable Opinion