Study for Mitral Valve Replacement

Trial ID:
IRB-17-7058
Matthew J Price, M.D.
This study will evaluate the safety and effectiveness of the Medtronic Intrepid™ Transcatheter Mitral Valve Replacement System in patients with severe mitral regurgitation that need a mitral valve replacement.

Eligible candidates will have screening testing done to make sure they can tolerate the procedure. Patients will be required to return for follow-up visits about 1-2 times per year for up to 5 years.

Inclusion Criteria

Patients must:
  • Have severe mitral regurgitation
  • Be at least 18 years old
  • Agree to return for all study visits
  • Meet all other eligibility criteria

Exclusion Criteria

Patients must not:
  • Have abnormal screening test results
  • Have had a previous mitral valve surgery
  • Have kidney disease
  • Have had a recent stroke or TIA

Additional Info

  • The Medtronic Intrepid™ valve is designed to be placed in the heart through a less invasive procedure that does not require cardiopulmonary bypass support, unlike a standard valve implant that requires open heart surgery.
  • Patients will be randomized, like the flip of a coin, to receive either the Intrepid™ valve or traditional mitral valve surgery.

Contact Info:

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