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| ID | Type | Description | Link |
|---|---|---|---|
| Beijing Jiekai Cardiovascular | Other Identifier | Beijing Jiekai Cardiovascular Health Foundation |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structural Heart Surgery Assist System-assisted TEER. | Experimental |
| |
| Manual TEER (e.g., MitraClip G4). | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Structural Heart Surgery Assist System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Success Rate | All of the following conditions need to be met
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 | 7days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Age ≥18 years, regardless of gender.
Symptomatic moderate-to-severe or greater mitral regurgitation (MR ≥3+) confirmed by transthoracic and/or transesophageal echocardiography (TTE/TEE), with planned transcatheter edge-to-edge repair (TEER):
For degenerative mitral regurgitation (DMR):
-Deemed high-risk for surgical intervention by the heart team:STS score ≥8% for mitral valve replacement (MVR) mortality risk; ≥6% for mitral valve repair mortality risk; OR presence of ≥2 frailty indices (moderate-to-severe frailty); OR anatomical/technical barriers to surgery; OR ≥2 major organ dysfunctions unlikely to improve postoperatively; OR other high-risk factors per heart team assessment.OR patient declines surgery.
For functional mitral regurgitation (FMR):
Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant).
Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiang Chen, Dr | Contact | 18033997788 | seanchenx@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Structural Heart Disease Unit, Xiamen Cardiovacular Hospital | Recruiting | Xiamen | Fujian | 361000 | China |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Manual MitraClip G4 | Device | Manual MitraClip G4 |
|
| Perioperative/Periprocedural |
| Clinical Success Rate | Criteria (all must be met):
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 | 7days |
| 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. | 7days/30days |
| Change in NYHA Functional Class | Assessed by comparing baseline NYHA class to class at 30 days post-procedure. | 30days |
| Mitral Clip Implantation Time | Definition: Time from transseptal puncture initiation to successful withdrawal of the steerable guide catheter. | Perioperative/Periprocedural |
| Fluoroscopy Time | Recorded using digital subtraction angiography (DSA) and defined as the cumulative X-ray exposure time from procedure start (defined as the first of: vascular access, anesthesia induction, or transesophageal echocardiography [TEE] probe insertion) to successful withdrawal of the steerable guide catheter. | Perioperative/Periprocedural |
| Operator Radiation Exposure | Measured using radiation dosimeters worn by the operator, recording cumulative radiation dose from procedure start to guide catheter withdrawal | Perioperative/Periprocedural |