CardioMech Mitral Valve Repair System (MVRS) Early Feasibility Study

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 - 99 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants who are willing and capable of participating in all study required testing, assessments and follow-up clinic visits
    2. Femoral vein access and transseptal catheterization are feasible
    3. Participants who are symptomatic (NYHA class II, III or ambulatory IV)
    4. CardioMech MVRS implant procedure is performed on an elective basis
    5. Participants who are intermediate or high surgical risk for mitral valve repair

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

    1. Women who are pregnant, lactating, or planning to become pregnant during the clinical study
    2. Participants with comorbidities, illnesses or social conditions that may compromise their ability to comply with any study requirement
    3. Participants currently participating or planning to participate in a study that may clinically affect this protocol’s study endpoints
    4. Participant or legal guardian is unable or unwilling to give informed consent
    5. Participant has had any cardiac or non-cardiac surgical or interventional procedure performed within 30 days prior
    6. History of prior repair or replacement of the mitral valve, annuloplasty or valvuloplasty or has a left atrial appendage closure device
    7. Has known hypersensitivity or contraindications to necessary medications including contrast compounds or components used in the CardioMech MVRS device that cannot be successfully pre-medicated, including nitinol, an alloy of nickel and titanium
    8. Has severe respiratory distress, pulmonary edema, or myocarditis
    9. History of bleeding diathesis or coagulopathy or an active peptic ulcer or GI bleeding in past 90 days
    10. Has chronic renal failure
    11. Has acute or active infection requiring oral or intravenous antibiotic therapy, or elevated temperature or white blood cell count that may be due to infection
    12. Has documented TIA or stroke within 90 days of the planned implant date or any prior stroke with a permanent neurologic deficit or any prior intracranial bleed
    13. Has had a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 90 days of the planned implant date
    14. Has severe chronic obstructive pulmonary disease (COPD) either requiring continuous home oxygen or oral corticosteroids
    15. Participants with prior mediastinal or left sided radiotherapy
    16. Has life expectancy less than 12 months per investigator assessment
    17. Has presence of an inferior vena cava (IVC) filter, a permanent pacemaker/ICD or pacing leads
    18. Hemodynamically unstable at baseline and preoperatively
    19. Has ACC Stage D or NYHA class IV b heart failure
    20. History of rheumatic heart disease
    21. History of prior endocarditis
    22. Has left ventricular thrombus or left atrial thrombus present on TTE or TEE
    23. Has severe tricuspid regurgitation and/or signs of severe RV dysfunction
    24. Has severe pulmonary hypertension
    25. Has echocardiographic evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease
    26. Has left ventricular ejection fraction (LVEF) =30%
    27. Participants who have evidence of acute myocardial infarction in the prior 90 days of the index implant procedure



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