ATLAS - A Transseptal Left Atrial System for Treatment of Mitral Regurgitation
- Trial ID:
- IRB-24-8467
- Curtiss Stinis, MD
Inclusion Criteria
Patients must:
- Be 18 years of age and older
- Be symptomatic by New York Heart Failure Association (NYHA) Class II - IV
- Have Moderate to Severe Mitral Regurgitation as determined by independent echo core lab despite optimal guideline-directed medical therapy (GDMT)
- Be Unsuitable for Mitral Valve surgery or Mitral Transcatheter Edge-to-Edge repair surgery (TEER), determine by cardiothoracic surgeon and interventional cardiologist
- Be able to walk at least 100 meters
Exclusion Criteria
Patients must not:
- Be currently enrolled in any other pre-approval investigational trial.
- Have a need for emergent or urgent surgery
- Have had a previous heart transplant
- Have renal insufficiency or end stage renal disease, advanced Liver disease, or a history or diagnosis of amyloidosis
- Have active cancer