NCT03271762进行中（未招募）不适用
Multicentre and Randomized Study of MITRACLIP® Transcatheter Mitral Valve Repair in Patients With Severe Primary Mitral Regurgitation Eligible for High-risk Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 330
- 试验地点
- 39
- 主要终点
- All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention
研究概览
简要总结
The objective of the study is to demonstrate the non-inferiority for clinical efficacy of an endovascular treatment strategy with the MitraClip® in comparison with a surgical treatment strategy in patients with severe primary mitral regurgitation judged eligible for anatomical repair with the MitraClip® or mitral valve surgery with high surgical risk.
This trial is a French and Monegasque, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years ( clinical visit at 1 month, at 6 months and 12 months, phone call at 18 months and clincial visit at 24 months).
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
- •Primary Mitral Regurgitation grade 3+ or 4+
- •Patients in class II to IV NYHA
- •Mitral valve anatomy appropriate to MitraClip® therapy and mitral valve surgery
- •Adult patients judged eligible for mitral valve surgery by the local heart team but at high surgical risk defined as: age ≥ 75 years and STS score ≥ 6 % or one frailty index or one major organ system compromise or one possible procedure-specific impediment (using MVARC definitions) ; or age < 75 years and STS score > 8 % or at least one other high-risk criterion following the MVARC definitions; or age > 80 years and judged at high risk for surgery by the local heart team
- •Isolated Mitral valve pathology
- •If revascularization procedures are required, they must be performed more than 30 days from intervention (D0)
- •Patients affiliate to social security
- •Non-inclusion Criteria:
- •Life expectancy < 1 year due to non-cardiac conditions
- •Secondary Mitral regurgitation
- •Evolving endocarditis or active endocarditis or inflammatory disease in the last 3 months
- •Patient who cannot tolerate procedural anticoagulation or post procedural antiplatelet regimen
- •Rheumatic mitral valve disease
- •Evidence of intracardiac, inferior vena cava or femoral venous thrombus
- •Valve anatomy not compatible with MitraClip® implantation (cf. colum 3 table 3 page 57)
- •Stroke or transient ischaemic event within 30 days before D0
- •Modified Rankin Scale ≥4 disability (appendix 9)
- •TAVR within 30 days before D0-Untreated, clinically significant coronary artery disease requiring revascularization
- •Any percutaneous cardiovascular intervention within 30 days before D0 including ATC
- •Cardiovascular surgery, or carotid surgery within 30 days before D0
- •Any prior mitral valve surgery or transcatheter mitral valve procedure
- •Need for any concomitant cardiac surgery including treatment of severe secondary tricuspid regurgitation in accordance with class I recommendation in 2017 ESC guidelines. Surgical treatment of mild or moderate secondary tricuspid regurgitation (Class IIa and IIb recommendations) can still be performed in the protocol according to the local heart team decison
- •NYHA functional class I
- •LVEF < 30%
- •Primary MR grade 1 to 2
- •Subjects in whom transesophageal echocardiography or transseptal catheterization are contraindicated or high-risk
- •Any condition preventing the patient from completing all protocol procedures (including compliance with guidelines directed medical therapy) and follow-up visits
- •Patient unable or unwilling to provide written, informed consent before study enrolment
- •Pregnant or nursing women
- •Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship
- •Participation in another trial that would interfere with this trial
- •Exclusion criteria
- •Not eligible for a MitraClip® intervention after Core Lab evaluation
- •Before randomization (D-21) the patient no longer fulfills eligibility criteria (inclusion criteria and non-inclusion criteria)
排除标准
- 未提供
结局指标
主要结局
All-cause mortality, unplanned hospitalizations for heart failure and mitral valve reintervention
时间窗: 12 months
comparison between arms of: * number and reason of death * number and reason unplanned rehospitalisation for cardiovascular reasons, * number of mitral valve reintervention
次要结局
- occurrence of a major adverse event(30 days)
研究者
研究点 (39)
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