Aortic Valve replacement for low risk surgery patients (EVOLUTR valve)

Trial ID:
IRB-16-6797
Paul S. Teirstein, M.D., FACC
The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.
*Have severe aortic stenosis <br>*Be considered low risk for traditional Aortic valve surgery<br>*Meet all other eligibility criteria

Contact Info:

  • Heather Catchpole
  • Catchpole.heather@scrippshealth.org
  • 858-824-4248

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