Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

NARecruitingINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

March 22, 2025

Primary Completion Date

March 22, 2026

Study Completion Date

April 22, 2026

Conditions
Mitral RMitral Regurgitation
Interventions
DEVICE

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.

DEVICE

Manual MitraClip G4

Manual MitraClip G4

Trial Locations (1)

361000

RECRUITING

Structural Heart Disease Unit, Xiamen Cardiovacular Hospital, Xiamen

All Listed Sponsors
lead

Xiamen Cardiovascular Hospital, Xiamen University

OTHER