112
Participants
Start Date
March 22, 2025
Primary Completion Date
March 22, 2026
Study Completion Date
April 22, 2026
Structural Heart Surgery Assist System
Following femoral venous access and transseptal puncture, the steerable guide catheter and transcatheter mitral valve clip system are inserted and mounted onto the Structural Heart Surgery Assist System. The surgeon manipulates the joystick and controls on the operator console, guided by real-time animations on the human-machine interface that confirm the direction and range of device motion. Under fluoroscopic (DSA) and echocardiographic guidance, the system assists in performing edge-to-edge mitral valve repair. The procedure achieves regurgitation reduction by either creating a double-orifice configuration (A2/P2 segments) or approximating the opposing leaflets at the A1/P1 or A3/P3 regions.
Manual MitraClip G4
Manual MitraClip G4
RECRUITING
Structural Heart Disease Unit, Xiamen Cardiovacular Hospital, Xiamen
Xiamen Cardiovascular Hospital, Xiamen University
OTHER