ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation) Pivotal Trial
4C Medical Technologies, Inc.
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…