Mitral R, Mitral Regurgitation
Conditions
Brief 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).
Interventions
DEVICEStructural 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.
DEVICEManual MitraClip G4
Manual MitraClip G4
Sponsors
Xiamen Cardiovascular Hospital, Xiamen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, regardless of gender. 2. 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): * 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. 3. Primary regurgitant jet is non-commissural and deemed treatable by the investigator (secondary jets, if present, must be clinically insignificant). 4. Volunteerly provides informed consent, understands the trial objectives, and agrees to comply with follow-up.
Exclusion criteria
1. Rheumatic mitral valve disease. 2. Uncorrected active infection. 3. Severe calcification or thickening in the clip coaptation zone, rendering TEER anatomically unsuitable. 4. Intracardiac mass, thrombus, or vegetation on echocardiography. 5. Severe right heart dysfunction (e.g., lower extremity edema with elevated jugular venous pressure and hepatomegaly) or severe pulmonary hypertension (echocardiographic systolic pulmonary artery pressure \>70 mmHg). 6. Severe left heart dysfunction (LVEF \<20%). 7. Acute myocardial infarction (AMI) within 30 days prior to the procedure. 8. Recent CABG, PCI, or TAVR within 30 days prior to the procedure. 9. Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure. 10. Prior surgical or transcatheter mitral valve repair/replacement. 11. Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement. 12. Stroke/TIA within 30 days or severe carotid stenosis (\>70% by ultrasound). 13. Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis. 14. Hemodynamic instability: Systolic blood pressure \<90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support. 15. Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure. 16. End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant. 17. Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes intervention. 18. Pregnant or breastfeeding. 19. Participation in other clinical trials (drug/device) without meeting primary endpoints. 20. Other contraindications per investigator judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Success Rate | 7days | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate | 7days | 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 | 7days/30days | 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 | 30days | Assessed by comparing baseline NYHA class to class at 30 days post-procedure. |
| Instrumental technique success (trial group only) | Perioperative/Periprocedural | 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 |
| Fluoroscopy Time | Perioperative/Periprocedural | 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. |
| Operator Radiation Exposure | Perioperative/Periprocedural | Measured using radiation dosimeters worn by the operator, recording cumulative radiation dose from procedure start to guide catheter withdrawal |
| Mitral Clip Implantation Time | Perioperative/Periprocedural | Definition: Time from transseptal puncture initiation to successful withdrawal of the steerable guide catheter. |
Countries
China
Contacts
Primary ContactXiang Chen, Dr
Outcome results
None listed