This is a prospective, single arm, multicenter, clinical trial designed to evaluate the safety and performance of the AltaValve System for the treatment of mitral regurgitation in a targeted patient population.
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.)).
Single group
AltaValve System.
DeviceTranscatheter Mitral Valve Replacement.
Composite of all-cause mortality or heart failure hospitalization.
All-cause mortality, disabling stroke, acute kidney injury (stage 3 or with renal replacement), mitral valve re-intervention (surgical or transcatheter), major bleeding requiring intervention.
Composite.
Technical success.
Technical success will be considered achieve when all of the following are present: * Successful application of the delivery system as intended. * Successful device placement. * Reduction in mitral regurgitation grade to ≤ 2+.
Mitral valve re-intervention.
Mitral valve re-intervention after index procedure
Changes in Kansas City Cardiomyopathy Questionnaire (KCCQ).
Quality of life improvement.
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