Clinical Trial

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

Recruiting
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Record status
This record was last updated July 9, 2025 (before its estimated March 22, 2026 completion). Its status may not reflect the trial's current state.
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).
Trial Details
NCT Number NCT07055919
Lead Sponsor Xiamen Cardiovascular Hospital, Xiamen University
Conditions Mitral R, Mitral Regurgitation
Enrollment 112 participants
Start Date 2025-03-22
Primary Completion 2026-03-22 (estimated)
Study Completion 2026-04-22 (estimated)
Updated on ClinicalTrials.gov 2025-07-09