IRB Study Number 21-772
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system
Inclusion Criteria
- Moderate-severe or severe mitral , either DMR (Degenerative Mitral Regurgitation) or FMR (Functional Mitral Regurgitation)
- Symptomatic mitral regurgitation (NYHA Class II-IV) despite optimal guideline directed medical therapy (GDMT)
- Deemed to be at elevated risk for conventional mitral valve surgery by the local heart team
- Other Inclusion Criteria will be assessed by study personnel
Exclusion Criteria
- Severe pulmonary hypertension
- Prior mitral valve surgery or endovascular procedure, any currently implanted mechanical prosthetic valve not allowing adequate TEE imaging window, or need for other valve surgery/procedure
- Any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to enrollment
- Other Exclusion Criteria will be assessed by study personnel
