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).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Surgical Success Rate
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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):
- •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.
- •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.
排除标准
- •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.
- •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).
- •Severe left heart dysfunction (LVEF <20%).
- •Acute myocardial infarction (AMI) within 30 days prior to the procedure.
- •Recent CABG, PCI, or TAVR within 30 days prior to the procedure.
- •Planned tricuspid/aortic valve or major vascular intervention within 30 days post-procedure.
- •Prior surgical or transcatheter mitral valve repair/replacement.
- •Thrombosis in access vessels (e.g., femoral vein, inferior vena cava) impeding catheter advancement.
- •Stroke/TIA within 30 days or severe carotid stenosis (>70% by ultrasound).
- •Cardiomyopathies or conditions including hypertrophic, restrictive, or infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis), constrictive pericarditis, or active endocarditis.
- •Hemodynamic instability: Systolic blood pressure <90 mmHg without afterload-reducing agents, cardiogenic shock, requirement for intra-aortic balloon pump (IABP) or hemodynamic support.
- •Implanted pacemaker, CRT, or ICD within 30 days prior to the procedure.
- •End-stage heart failure (ACC/AHA Stage D), post-heart transplant, or listed for transplant.
- •Hypersensitivity or contraindications: ntolerance to anticoagulants, antiplatelet agents, or anesthesia, allergy to mitralclip materials (nickel/titanium, cobalt, chromium, polyester), severe contrast allergy precludes intervention.
- •Pregnant or breastfeeding.
- •Participation in other clinical trials (drug/device) without meeting primary endpoints.
- •Other contraindications per investigator judgment.
结局指标
主要结局
Surgical Success Rate
时间窗: 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
Surgical Success Rate
时间窗: 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
次要结局
- Instrumental technique success (trial group only)(Perioperative/Periprocedural)
- Clinical Success Rate(7days)
- Change in Mitral Regurgitation (MR) Severity(7days/30days)
- Change in NYHA Functional Class(30days)
- Mitral Clip Implantation Time(Perioperative/Periprocedural)
- Fluoroscopy Time(Perioperative/Periprocedural)
- Operator Radiation Exposure(Perioperative/Periprocedural)
- Instrumental technique success (trial group only)(Perioperative/Periprocedural)
- Clinical Success Rate(7days)
- Change in Mitral Regurgitation (MR) Severity(7days/30days)
- Change in NYHA Functional Class(30days)
- Operator Radiation Exposure(Perioperative/Periprocedural)
研究者
Yan Wang
Principal Investigator
Xiamen Cardiovascular Hospital, Xiamen University