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:
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Conditions: Mitral Regurgitation
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Age: Between 18 - 99 Years
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Gender: Male or Female
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Other Inclusion Criteria:
- Participants who are willing and capable of participating in all study required testing, assessments and follow-up clinic visits
- Femoral vein access and transseptal catheterization are feasible
- Participants who are symptomatic (NYHA class II, III or ambulatory IV)
- CardioMech MVRS implant procedure is performed on an elective basis
- 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:
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- Women who are pregnant, lactating, or planning to become pregnant during the clinical study
- Participants with comorbidities, illnesses or social conditions that may compromise their ability to comply with any study requirement
- Participants currently participating or planning to participate in a study that may clinically affect this protocol’s study endpoints
- Participant or legal guardian is unable or unwilling to give informed consent
- Participant has had any cardiac or non-cardiac surgical or interventional procedure performed within 30 days prior
- History of prior repair or replacement of the mitral valve, annuloplasty or valvuloplasty or has a left atrial appendage closure device
- 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
- Has severe respiratory distress, pulmonary edema, or myocarditis
- History of bleeding diathesis or coagulopathy or an active peptic ulcer or GI bleeding in past 90 days
- Has chronic renal failure
- 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
- 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
- Has had a deep vein thrombosis (DVT) or pulmonary embolism (PE) within 90 days of the planned implant date
- Has severe chronic obstructive pulmonary disease (COPD) either requiring continuous home oxygen or oral corticosteroids
- Participants with prior mediastinal or left sided radiotherapy
- Has life expectancy less than 12 months per investigator assessment
- Has presence of an inferior vena cava (IVC) filter, a permanent pacemaker/ICD or pacing leads
- Hemodynamically unstable at baseline and preoperatively
- Has ACC Stage D or NYHA class IV b heart failure
- History of rheumatic heart disease
- History of prior endocarditis
- Has left ventricular thrombus or left atrial thrombus present on TTE or TEE
- Has severe tricuspid regurgitation and/or signs of severe RV dysfunction
- Has severe pulmonary hypertension
- Has echocardiographic evidence of intracardiac mass, vegetation, or inflammatory or infectious valve disease
- Has left ventricular ejection fraction (LVEF) =30%
- Participants who have evidence of acute myocardial infarction in the prior 90 days of the index implant procedure
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.