NCT04009434Unknown不适用
Treatment of Concomitant Mitral Regurgitation by Mitral Valve Clipping in Patients With Successful Transcatheter Aortic Valve Implantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 1,162
- 试验地点
- 1
- 主要终点
- Death from any cause and heart failure hospitalization
研究概览
简要总结
To evaluate whether patients after successful transfemoral transcatheter aortic valve implantation (TAVI), who have concomitant, moderate to severe mitral regurgitation (MR) benefit from an additional treatment of this valve disease as well.
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned transfemoral TAVI using an Edwards Sapien 3 Transcatheter Heart Valve (or subsequent models)
- •Moderate to severe mitral regurgitation
- •Symptom status NYHA II-III
- •Treatment and compliance with optimal, individually-tailored guideline directed medical therapy for heart failure for at least 30 days before inclusion
- •Age ≥ 18 and < 90 years
- •Written informed consent
排除标准
- •MR mechanism/anatomy precluding MitraClip therapy
- •Groin blood vessels are not eligible for TAVI procedure
- •Massive or torrential tricuspid regurgitation
- •Patients who cannot tolerate procedural anticoagulation or post procedural anti-platelet regimen.
- •Life expectancy < 1 year due to non-cardiac conditions
- •LVEF ≤ 25%
- •Hypotension (systolic pressure < 90 mmHg) or requirement of inotropic support or mechanical hemodynamic support
- •Cardiomyopathy other than dilated cardiomyopathy
- •Fixed pulmonary artery systolic pressure > 70 mm Hg
- •Any prior mitral valve surgery or transcatheter mitral valve procedure
- •Stroke or transient ischemic event within 6 months prior to randomization
- •Severe symptomatic carotid stenosis
- •Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter defibrillator within 90 days prior to randomization
- •Untreated clinically significant coronary artery disease requiring revascularization
- •Any percutaneous cardiac intervention or carotid surgery within the 30 days prior to randomization, or any cardiac surgery within six months prior to randomization.
- •Need for any other cardiovascular surgery (other than MV or AV disease)
- •Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- •Active endocarditis or active infections requiring current antibiotic treatment
- •Any condition making it unlikely that the patient will be able to complete all protocol procedures
- •Patient unable to provide written informed consent prior to study enrolment
- •Pregnant or nursing women
- •Women of child bearing potential
- •Current participation in any other interventional clinical trial
- •Patients under legal supervision or guardianship Patients placed in an institution by official or court order
研究组 & 干预措施
TAVI
Other
Transfemoral transcatheter aortic valve implantation plus optimal standard of care medical therapy
干预措施: TAVI (Device)
TAVI/MitraClip
Experimental
Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.
干预措施: Mitral Valve Clipping (Device)
TAVI/MitraClip
Experimental
Transfemoral transcatheter aortic valve implantation, mitral valve clipping plus optimal standard of care medical therapy.
干预措施: TAVI (Device)
结局指标
主要结局
Death from any cause and heart failure hospitalization
时间窗: 1 year
Composite endpoint of time to heart failure hospitalization or death from any cause
次要结局
- 6 Minute Walk Test(1 year)
- Death from any cause(1, 2, 3, 4 years)
- Need for mitral valve reintervention(1, 2, 3, 4 years)
- Mitral regurgitation severity(1 year)
- New York Heart Association Functional Class(1, 3, 6 months and 1, 2, 3, 4 years)
研究者
研究点 (1)
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