CLINICAL TRIAL AGREEMENT FOR THE 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 Valve Regurgitation
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    All Cohorts
    1. Subjects who have moderate to severe or severe symptomatic mitral regurgitation
    2. Subjects are candidates for bioprosthetic mitral valve replacement
    3. Subjects will return for all required post-procedure follow-up visits
    4. Subjects who are able to provide voluntary written informed consent

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

  • Randomized Cohort
    1. Subjects 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. Subjects with estimated life expectancy of less than 24 months due to associated non-cardiac co-morbid conditions
    3. Subjects with mitral anatomy that would preclude management of the sub-valvular apparatus and/or full chordal sparing
    4. Subjects who have had prior mitral valve surgery including previously implanted mitral valve, ring, or band
    All Cohorts
    1. Subjects with prior transcatheter mitral valve procedure with device currently implanted
    2. Subjects with prohibitive mitral annular calcification
    3. Subjects who have aortic valve disease requiring intervention or previous intervention within 90 days of enrollment
    4. Subjects with severe tricuspid regurgitation
    5. Subjects with evidence of new or untreated intracardiac mass or thrombus
    6. Subjects who have right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction
    7. Subjects with pulmonary hypertension with resting pulmonary artery systolic pressures =2/3 systemic pressure
    8. Subjects with left ventricular ejection fraction (LVEF) <25% as measured by resting echocardiogram within 30 days of the Index Procedure
    9. Subjects with left ventricular end diastolic diameter (LVEDD) > 80mm
    10. Subjects who are contraindicated for transesophageal echocardiography (TEE)
    11. Subjects who needfor emergent or urgent surgery
    12. Subjects who have hemodynamic instability requiring dependency of either inotropic agents or mechanical circulatory support
    13. Subjects who refuse a blood transfusion
    14. Subjects unwilling or unable to adhere to the protocol specified anticoagulation treatment
    15. Subjects with blood dyscrasias
    16. Subjects who have history of bleeding diathesis or coagulopathy that precludes anticoagulation
    17. Subjects with active gastrointestinal (GI) bleeding that would preclude anticoagulation
    18. Subjects who have known hypersensitivity or contraindication to nitinol, or sensitivity to contrast media which cannot be adequately pre-medicated
    19. Subjects who have had any cardiac or peripheral interventional procedure performed within 30 days prior to enrollment
    20. Subjects with obstructive coronary artery disease requiring treatment
    21. Subjects who have severe symptomatic carotid stenosis
    22. Subjects who had recent stroke or TIA within 90 days of enrollment
    23. Subjects with evidence of an acute myocardial infarction within 90 days of enrollment
    24. Subjects with active endocarditis or active infection requiring antibiotic therapy
    25. Subjects who have had a implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT-D) within 90 days of enrollment
    26. Subjects with end stage renal disease requiring chronic dialysis or creatinine clearance < 20 cc/min
    27. Subjects with severe Chronic Obstructive Pulmonary Disease (COPD) demonstrated by Forced Expiratory Volume (FEV1) < 750cc
    28. Subjects who are pregnant or have the intent to become pregnant before the completion of all protocol follow up requirements
    29. Subjects participating in another investigational drug or another device study



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