IRB Study Number 20-148
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
Evaluate the safety and effectiveness of the Tendyne™ Transcatheter Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification
Inclusion Criteria
- Symptomatic, moderate-to-severe or severe mitral, or severe mitral annular calcification (MAC), where a transcatheter therapy is deemed more appropriate than conventional mitral valve surgery by the local site heart team.
- NYHA Functional Classification ≥ II
- The local site heart team determines that the subject has been adequately treated per applicable standards for coronary artery disease (e.g., revascularization), left ventricular dysfunction (e.g., cardiac resynchronization therapy) and heart failure (e.g., GDMT)
- Additional inclusion criterial will be assessed by study staff
Exclusion Criteria
- Mitral valvular vegetation or mass
- Left Ventricle (LV) or Left Atrium (LA) thrombus
- Chest condition that prevents transapical access
- Additional exclusion criteria will be assessed by study staff
