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Comparison of self-expanding vs balloon-expandable aortic valves.

Trial ID:
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.

Inclusion Criteria

Patients must:
  • Have severe aortic stenosis
  • Be willing to return for all required post-procedure follow-up visits

Exclusion Criteria

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

Additional Info

  • 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

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org