The objective of the MAVERIC 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).
ClinicalTrials.gov ID NCT02302872
Sponsor
MVRX, Inc
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
- Full Services
Countries
Australia, France, Italy, Latvia, South Africa and UK managed by CERC.
Number of investigational sites
13 centers managed by CERC.
Number of patients
51
