Brief summary

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).

Primary endpoints

• 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)

CERC Services

• Regulatory Submissions
• Project Management
• Monitoring
• Data Management
• CEC activities
• DSMB activities
• SAE reporting
• Core Laboratory

Countries

Australia, France, Italy, Latvia, South Africa and UK managed by CERC.

Center number

13 centers managed by CERC.