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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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.
Exclusion Criteria (Abbreviated List):
* 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 th…
What they're measuring
1
Composite of all-cause mortality or heart failure hospitalization.