- Patient in whom a TEE is contraindicated or screening TEE is unsuccessful
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Mitral valve anatomy which may preclude proper PASCAL or MitraClip access, use and/or deployment or sufficient reduction in mitral regurgitation
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End-stage Heart Failure with inotrope support or consideration for LVAD or heart transplant
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Clinically significant, untreated coronary artery disease
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Other severe valve disorders requiring intervention
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Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
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Any prior mitral valve surgery or transcatheter mitral valve procedure
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Active rheumatic heart disease or rheumatic etiology for MR
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Severe aortic stenosis or regurgitation
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Known history of severe symptomatic carotid stenosis
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History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
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Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception
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Concurrent medical condition with a life expectancy of less than 12 months in the judgment of the Investigator
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Patient is currently participating in another investigational biologic, drug or device clinical study where the primary study endpoint was not reached at time of enrollment
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Other medical, social, or psychological conditions that preclude appropriate consent and follow-up, including patients under guardianship
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