Transcatheter Mitral Valve Replacement with the Medtronic Intrepid TMVR System in patients with severe symptomatic mitral regurgitation APOLLO Trial

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 Year(s) - 110 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects have moderate to severe or severe symptomatic mitral regurgitation
    2. Heart Team agrees that patient is a candidate for bioprosthetic mitral valve replacement
    3. Subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits
    4. Subject meets the legal minimum age to provide informed consent based on local regulatory requirements

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

  • Randomized Cohorts
    1. Subject has comorbidities such that the Heart Team agrees predicted risk of operative mortality is <3% at 30 days or has =35% risk of mortality or irreversible major morbidity at 30 days
    2. Estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
    3. Subject with mitral anatomy that would preclude management of the sub-valvular apparatus and/or full chordal sparing
    4. Prior mitral valve surgery including previously implanted mitral valve, ring, or band
    All Cohorts
    1. Prior transcatheter mitral valve procedure with device currently implanted
    2. Anatomic contraindications for IntrepidTM TMVR
    3. Prohibitive mitral annular calcification
    4. Aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
    5. Severe tricuspid regurgitation
    6. Evidence of new or untreated intracardiac mass or thrombus
    7. Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
    8. Subject unwilling or unable to adhere to the protocol specified anticoagulation treatment
    9. Any cardiac or peripheral interventional procedure performed within 30 days prior to enrollment; within 90 days prior to enrollment for subjects treated with drug eluting stents (DES).
    10. Pregnancy or intent to become pregnant prior to completion of all protocol follow-up requirements
    11. Currently participating in an investigational drug or another device study that has not yet reached its primary endpoint
    12. 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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