Evaluation of the Safety and Performance of Medtronic Intrepid Transcatheter Mitral Valve Replacement System with Transfemoral Transseptal Access in Patients with Severe Symptomatic Mitral Regurgitation

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Mitral Regurgitation
  • Age: Between 18 - 110 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participant with severe symptomatic mitral regurgitation who are determined by a multidisciplinary heart team to be a candidate for bioprosthetic mitral valve replacement and are ineligible for conventional mitral valve surgery
    2. Anatomically suitable the Intrepid TMVR delivery system including transfemoral and transseptal access
    3. Participant is able to return for all required post-procedure follow-up visits
    4. Participants must provide written informed consent

You may not be eligible for this study if the following are true:

    1. Had a transcatheter mitral valve procedure with device currently implanted
    2. Had prior transseptal intervention with occlusion device currently implanted
    3. Anatomic contraindications for Intrepid™ TMVR
    4. Prohibitive mitral annular calcification
    5. Aortic valve disease requiring intervention
    6. Severe tricuspid regurgitation
    7. Evidence of intracardiac mass, inferior vena cava, or femoral venous mass or thrombus
    8. Implanted with venous stents
    9. Contraindicated for transesophageal echocardiography (TEE)
    10. Need for emergent or urgent surgery
    11. Unwilling or unable to adhere to the protocol specified anticoagulation treatment
    12. History of bleeding diathesis or coagulopathy
    13. Active gastrointestinal (GI) bleeding
    14. Known hypersensitivity or contraindication to nitinol
    15. Any cardiac or peripheral interventional procedure performed within 30 days prior
    16. Has obstructive coronary artery disease requiring treatment
    17. Severe symptomatic carotid stenosis
    18. Stroke or TIA within 90 days
    19. Acute myocardial infarction within 90 days
    20. Active endocarditis or active infection requiring antibiotic therapy
    21. Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within 90 days
    22. End stage renal disease
    23. Severe Chronic Obstructive Pulmonary Disease (COPD)
    24. Pregnant
    25. Currently participating in an investigational drug or another device study
    26. Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol required follow-up exams

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