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).
Age ≥18 years, regardless of gender.
Persistent heart failure symptoms (NYHA Class III/IVa) despite guidelines directed medical therapy (GDMT), revascularization, or cardiac resynchronization therapy (CRT) for 1-3 months.
≥1 hospitalization for heart failure within the past 12 months and/or BNP >150 pg/mL or NT-proBNP >600 pg/mL.
Left ventricular ejection fraction (LVEF) ≥20% and ≤50%, with left ventricular end-systolic diameter (LVESD) ≤70 mm.
Rheumatic mitral valve disease.
Uncorrected active infection.
Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable.
Intracardiac mass, thrombus, or vegetation on echocardiography.
Parallel
Structural Heart Surgery Assist System
DeviceFollowing 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
DeviceManual MitraClip G4
Surgical Success Rate
All of the following conditions need to be met 1. Successful implantation of 1 or more mitral clips (successful delivery and release of mitral clips with echocardiographic confirmation of leaflet clamping and successful withdrawal of the transcatheter mitral clip delivery system and manoeuvrable guide catheter); 2. Transthoracic echocardiography showing a degree of mitral regurgitation ≤2+ (as evaluated by a third-party core laboratory) prior to discharge (up to 7 days). Calculation formula: Surgical success rate (%) = (number of cases achieving surgical success in each group/total number of cases in each group) × 100% for each group
Instrumental technique success (trial group only)
Definition: Successful completion of transcatheter mitral valve edge-to-edge repair (TEER) using the Structural Heart Surgery Assist System without unplanned manual intervention. Unplanned Manual Intervention: Defined as conversion to manual operation during stages that the system is designed to assist (clip delivery and leaflet capture), per the Instructions for Use of the Structural Heart Surgery Assist System. Calculation formula: Instrumental technique success (%) = (number of cases achieving Instrumental technique success in trial group/total number of cases in trial group) × 100% for each group
Clinical Success Rate
Criteria (all must be met): 1. No intraoperative mortality related to the procedure. 2. Successful delivery and deployment of the mitral valve clip, with retrieval of the transcatheter clip delivery system and steerable guide catheter. 3. Placement of ≥1 mitral valve clip in the anatomically correct position. 4. No unplanned surgeries or reinterventions related to the device or access site prior to discharge (within 7 days maximum). Calculation formula: Clinical Success Rate (%) = (number of cases achieving Clinical Success in each group/total number of cases in each group) × 100% for each group
Change in Mitral Regurgitation (MR) Severity
Assessed by comparing baseline Mitral Regurgitation (MR) Severity 7days and 30 days post-procedure. The severity of mitral regurgitation was classified as absent (0+), mild (1+), moderate (2+), moderately severe (3+), and severe (4+). Evaluation method: based on transthoracic echocardiography results.
Change in NYHA Functional Class
Assessed by comparing baseline NYHA class to class at 30 days post-procedure.
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