NCT05021614招募中不适用
Evaluation of the Efficacy and Safety of the Transcatheter Mitral Valve Repair System in Patients With Moderate and Above Degenerative Mitral Regurgitation at High Surgical Risk
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Efficacy of product
研究概览
简要总结
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
详细描述
This study is a prospective,multi-center, single-arm, safety and performance clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe mitral regurgitation≥3+ (moderate or above degenerative mitral regurgitation disease, or with stenosis is included);
- •Age≥70 years; or patients who are 60~70 years old, and the STS risk score indicate that participants are at high risk of traditional surgery or cannot tolerate traditional thoracotomy;
- •Left ventricular ejection fraction≥30%； 5) As assessed by multidisciplinary cardiac team (at least two cardiac surgeons/one cardiologist), patients who are at extremely high-risk or unsuitable for routine mitral valve surgery with evaluation; 6) Patients who understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
- •Anatomy selection Criteria：
- •The regurgitant jet of mitral valve originates from the A2 and P2 (the lesions of A2/P2 in mitral valve causes regurgitation);
- •The width of the mitral valve prolapsed area is ≤15mm, Height of Prolapse ≤10mm or coaptation depth≤11mm, coaptation height≥2mm, effective length of anterior and posterior leaflets>1cm (conforming to EVEREST II recommended mitral valve interventional edge-to-edge repair standards);
- •Effective mitral valve orifice area≥ 4.0cm2;
- •No obvious calcification of the mitral valve annulus and valve leaflets;
- •Patient's anatomical conditions allow transseptal approach.
排除标准
- •Previous cardiac mitral valve surgery;
- •Patients with Infective endocarditis or having an active infection;
- •Patients with mitral regurgitation caused by pure mitral stenosis;
- •Combined with untreated severe coronary artery disease
- •Pulmonary hypertension (pulmonary artery systolic pressure>70mmHg);
- •Patients with severe right heart failure;
- •Patients are extremely weak and cannot tolerate general anesthesia or are in shock that circulatory support is needed;
- •Patients with hypertrophic cardiomyopathy, restrictive cardiomyopathy, and constrictive pericarditis;
- •Patients receiving chronic dialysis;
- •Patients with clear coagulation dysfunction and severe coagulopathy;
- •Patients with clear contraindications to anticoagulant drugs;
- •Patients with stroke or transient ischemic attack within 30 days;
- •Echocardiography found any intracardiac mass, left ventricle or atrial thrombus;
- •Patients who require surgery or interventional therapy for other valvular lesions;
- •Patients with severe macrovascular lesions requiring surgical treatment;
- •Patients' imaging examinations suggest that the anatomy of the heart and valves are inappropriate;
结局指标
主要结局
Efficacy of product
时间窗: 12 months
Efficacy of product is defined as the proportion of participants meeting effective standards after surgery (freedom from death, mitral valve reoperation or MR\>2+ at 12 months).
次要结局
- Rate of Severe adverse events(30 days, 180 days, 1 year, 2 to 5 years)
- Efficacy of product(30 days, 180 days, 2 to 5 years)
- Quality of life Improvement(30 days, 180 days, 1 year, 2 to 5 years)
- Rate of Cardiovascular related mortality(30 days, 180 days, 1 year, 2 to 5 years)
研究者
研究点 (1)
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