The objective of the study is to evaluate the safety and performance of the ARTO System in patients with mitral valve regurgitation (MR) associated with congestive heart failure (CHF).
- Major Adverse Event Rate to 30 days post-procedure (death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, renal failure)
- Mitral Regurgitation grade and change from baseline to 30 days
- Device Technical Success (At exit from cath lab, alive, with Successful access, delivery and retrieval of the device delivery system, and Deployment and correct positioning (including repositioning/recapture if needed) of the single intended device, and No need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure)
- Regulatory Submissions
- Project Management
- Data Management
- CEC activities
- DSMB activities
- SAE reporting
- Core Laboratory
Australia, France, Italy, Latvia, South Africa and UK managed by CERC.
13 centers managed by CERC.