Trial Search Results

Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation

Multi-center, global, prospective, randomized, interventional, pre-market trial with two subject groups: the randomized group will be randomized on 1:1 basis to either the study device or to conventional mitral valve surgery. Subjects in the single-arm group will receive the study device.

Subjects will be seen at pre- and post-procedure, discharge, 30 days, 6 months, and annually through 5 years.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Medtronic Cardiovascular

Intervention(s):

  • Device: Medtronic Intrepid Transcatheter Mitral Valve Replacement System (TMVR)
  • Device: Surgical Mitral Valve Replacement (SMVR)

Phase:

N/A

Eligibility


Inclusion Criteria:

   - moderate to severe or severe symptomatic mitral regurgitation

   - candidate for bioprosthetic mitral valve replacement, as determined by heart team

Exclusion Criteria:

   - prior transcatheter mitral valve procedure with device currently implanted

   - anatomic contraindications

   - prohibitive mitral annular calcification

   - left ventricular ejection fraction <25%

   - need for emergent or urgent surgery

   - hemodynamic instability

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting