Comparison of self-expanding vs balloon-expandable aortic valves.
Paul S. Teirstein, M.D., FACC
This study will compare the safety and performance of the Medtronic Evolut PRO/PRO+ self-expanding heart valve system to the Edwards SAPIEN 3/3 balloon-expandable Ultra heart valve system for transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis. Both devices are FDA approved and commercially available.
Have severe aortic stenosis
Be willing to return for all required post-procedure follow-up visits
Patients must not:
Have had a previous aortic valve replacement
Have multi-vessel coronary artery disease
have an active COVID-19 infection within the last 3-months
Eligible patients will be randomized to receive either the EVOLU R valve or the Sapien 3 valve and will have post-procedure follow-up visits at 30 days and 12 months, then annually for up to 5 years. All treatments and patient visits during this study will take place at Scripps Memorial Hospital.
For more information, search for NCT04722250 at www.clinicaltrials.gov