IRB Study Number 25-014
Status Recruiting
Institute Heart and Vascular Institute
Description
The purpose of this clinical trial is to evaluate the safety and effectiveness of the AltaValve System in the treatment of moderate-to-severe and severe Mitral Regurgitation in a targeted patient population.
Inclusion Criteria
- Symptomatic New York Heart Association class II-IV.
- Moderate to Severe of Severe Mitral Regurgitation despite optimal guideline-directed medical therapy as determined by independent Core Lab.
- Unsuitable for MV surgery and TEER as determined by the site Heart Team.
Exclusion Criteria
- History of cognitive or mental health status that would interfere with participation in the trial.
- Female subjects who are pregnant or planning to become pregnant.
- Known hypersensitivity or contraindication to heparin or warfarin without adequate alternative medications.
