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Study for Mitral Valve Replacement

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

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

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

Exclusion Criteria

  • 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