DRKS00008923进行中（未招募）4 期
High and Intermediate Risk Degenerative Mitral Regurgitation Treatment: a Randomized Controlled Trial Comparing MitraClip® to Surgical Therapy - HiRiDe Trial
Klinikdirektor, Klinik für Herz- und Gefäßchirurgie0 个研究点目标入组 5 人开始时间: 2015年7月29日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Severe (4+) DMR (degenerative mitral regurgitation), or 3+ DMR
- •- NYHA Functional Class III or IV
- •- Mitral valve anatomy should be suitable for both MitraClip® and Mitral valve surgery (repair or replacement)
- •- Subjects meet the following conditions:
- •Age >=18 and high or intermediate risk with STS calculated mortality (using the repair calculator) >=3% and <=10% or as determined by the local Heart Team (which should include a surgeon and a cardiologist), based on the evidence that STS risk calculator may not identify possible risk factors
- •- Patient is operable
- •- Signed by the subject and dated approved informed consent prior to any study related procedure
- •- Available and able to return to study site for post-procedural follow-up examination
排除标准
- •- Patient incapable to approve the informed consent or Emergency Cases
- •- functional mitral valve pathology
- •- evolving endocarditis or active endocarditis in the last 3 months
- •- heavily calcified leaflets
- •- subjects in whom transesophageal echocardiography is contraindicated
- •- subjects in whom transseptal catheterisation is contraindicated
- •- presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year
- •- currently participating in the study of an investigational drug or device
- •- untreated clinically significant CAD requiring revascularisation
- •- any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
- •- prior mitral valve leaflet surgery or any currently implanted prosthetic mitral valve, or any prior transcatheter mitral valve procedure
- •- concomitant and significant aortic or tricuspid valve pathology
- •- CVA or TIA within 6 months or severe carotid stenosis (>70% assessed by Ultrasound)
- •- contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately managed with premedication
研究者
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终止
4 期
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