NCT04954404招募中不适用
Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
详细描述
Prospective, single-arm, single-center clinical evaluation of transcatheter mitral valve intervention in subjects with mitral valve disease who are treated per standard of care and who have been determined by the local heart team as appropriate for interventional treatment. Eligible subjects will be treated by transcatheter mitral valve repair or transcatheter mitral valve replacement.
This single-arm registry will provide valuable new information regarding use of multiple mitral valve interventional devices and evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mitral valve disease, as determined by the site from a transthoracic echocardiogram (TTE), and in the judgment of the investigator intervention is likely to provide clinical benefit for the patient.
- •Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
- •The subject agrees to comply with specified follow-up evaluations and to return to the investigational site where the procedure was performed.
- •Patients are technical and anatomical eligible for interventions.
排除标准
- •In the judgment of the investigator, subjects are not anatomical eligible for interventions.
- •Known hypersensitivity or contraindication to procedural medications which cannot be adequately managed medically.
- •Active endocarditis or active rheumatic heart disease.
- •History of severe bleeding diathesis or coagulopathy or subject will refuse blood transfusions.
- •Subject has any kind of conditions that might prevent patients benefiting from therapeutic benefit (i.e., Severe mental illness) or life expectancy is less than one year.
- •Subject has any kind of disorder per investigator's judgement that compromises his/her ability to give written informed consent and/or to comply with study procedures.
结局指标
主要结局
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
时间窗: 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years
Composite outcomes of all-cause mortality and rate of rehospitalization related to heart failure.
次要结局
- Vascular complications(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Quality of life improvement(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Change of cognitive function(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Significant iatrogenic atrial septal defect(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Effective regurgitant orifice area(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Mean mitral valve gradient(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Rehospitalization related to heart failure(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Stroke(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Transient ischemic attack(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Brain lesion(Predischarge)
- All-cause mortality(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Cardiovascular mortality(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Myocardial infarction(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Permanent pacemaker implantation(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Device success(Immediately after procedure)
- Infective endocarditis(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Bleeding events(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Recurrent hospitalization - All cause(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Acute kidney injury(Predischarge, 30 days)
- New-onset atrial fibrillation(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Change of New York Heart Association functional classification(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- MR and/or MS severity(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Modified Rankin scale score(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- 6-min walk test(30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Reintervention of mitral valve(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Device embolization or single leaflet device attachment(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Regurgitant fraction(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Regurgitant volume(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Mitral valve area(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Left ventricular end-diastolic diameter (LVEDD)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Left ventricular end-systolic diameter (LVESD)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- BNP and/or NT-proBNP levels(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Left ventricular ejection fraction (LVEF)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Pulmonary artery systolic pressure (PASP)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Right ventricular systolic pressure (RVSP)(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
- Left ventricular mass(Predischarge, 30 days, 6 months, 1 year, 2 years, 3 years, 5 years, 10 years)
研究者
研究点 (1)
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