Design Prospective, non-randomized, multi-site interventional clinical trial within the united States of america with each center following a common protocol. objectives To evaluate the safety and effectiveness of MaSa Valve over the period of implant. end Points Primary endpoints a. Freedom from Device-related Death b. Freedom from explant c. Freedom from Device-related Reoperation d. Freedom from Device-related Catheter intervention Secondary endpoints a. echocardiography-based Hemodynamic Performance Metrics b. Regurgitation Classification
The proposed study is intended to support clearance a future Humanitarian Device exemption (HDe) application. as this will technically be a first-in-human study (FiH) for the MaSa Valve, this is considered an early Feasibility Study iDe Study. However, the device is understood to be in final, finished form with preclinical testing completed.
