AltaValve Pivotal Trial

Eligibility Criteria

• * Age ≥ 18 years.
• * Symptomatic New York Heart Association (NYHA) class II-IV.
• * Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
• * Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
• * Inability to understand the trial or a history of non-compliance with medical advice.
• * Inability to provide signed Informed Consent Form (ICF).
• * History of any cognitive or mental health status that would interfere with participation in the trial.
• * Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
• * Female subjects who are pregnant or planning to become pregnant within the trial period.
• * Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
• * Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
• * Known hypersensitivity to contrast media that cannot be adequately medicated.
• * Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
• * Concurrent medical condition with a life expectancy of less than 12 months.
• * Transcatheter aortic repair or replacement within 90 days prior to the index procedure.
• * Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.