NCT07055919

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

A Prospective, Multicenter, Stratified Randomized Controlled, Non-Inferiority Clinical Trial to Evaluate the Safety and Efficacy of the Structural Heart Surgery Assist System for Transcatheter Mitral Valve Edge-to-Edge Repair (TEER).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Xiamen Cardiovascular Hospital, Xiamen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).

Conditions

• Mitral R
• Mitral Regurgitation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-03-22
• Primary completion: 2026-03-22
• Completion: 2026-04-22
• First posted: 2025-07-09
• Last updated: 2025-07-09

Locations

1 site across 1 country: China