SMART Trial
Research type
Research Study
Full title
Small Annuli Randomized To Evolut or Sapien Trial
IRAS ID
292050
Contact name
Daniel Blackman
Contact email
Sponsor organisation
Medtronic Bakken Research Center B.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 3 months, 1 days
Research summary
The purpose of this study is to collect information and compare the safety and performance of balloon-expandable (BE) versus the self-expanding (SE) transcatheter aortic valve replacement (TAVR) in patients with a small aortic valve for treating the disease of the aortic valve which is called aortic stenosis. A procedure to replace the diseased aortic valve is the standard treatment for aortic stenosis. This can be done by open heart surgery, also called surgical aortic valve replacement, or by transcatheter aortic valve replacement, which does not require open heart surgery. In this study, TAVR will be performed. In a TAVR procedure, the transcatheter aortic valve (TAV) replacement device is inserted through a flexible tube (catheter). The catheter is inserted through an incision in the skin of the groin and threaded through the blood vessel. In this study, the patient will receive either a commercially available Medtronic self-expanding TAV or Edwards balloon-expandable TAV.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0050
Date of REC Opinion
13 Apr 2021
REC opinion
Further Information Favourable Opinion