NCT01920698已完成不适用
Multicentre Randomized Study of Percutaneous Mitral Valve Repair MitraClip Device in Patients With Severe Secondary Mitral Regurgitation.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 71
- 主要终点
- All-cause mortality and unplanned hospitalizations for heart failure
研究概览
简要总结
The objective of this trial is to compare the safety, the efficacy and the cost-effectiveness of 2 therapeutic strategies (optimal standard of care therapy alone versus percutaneous MitraClip procedure and optimal standard of care therapy) in patients with severe secondary mitral regurgitation.
This trial is a French, multicenter and randomized trial. Patients enrolled will be clinically followed for 2 years (phone call at 1 month, clinical visit at 6 months, 12 months and 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
- •Age > 18 years old
- •Severe secondary mitral regurgitation characterised, according to the European guidelines and recommendations, by a regurgitant volume>30 mL/beat or an effective regurgitant orifice>20 mm².
- •New York heart Association Class≥ II.
- •Left ventricular ejection fraction between 15% and 40%
- •Minimum of 1 hospitalization for heart failure within 12 months preceding randomization
- •Optimal standard of care therapy for heart failure according to investigator.
- •Not eligible for a mitral surgery intervention according to the Heart Team.
- •Willingness to participate in the study and signed written informed consent
- •Affiliation to a health insurance system or a similar system
排除标准
- •Eligible for a mitral surgery intervention according to the Heart Team.
- •Primary mitral regurgitation.
- •Myocardial infarction or coronary bypass grafting surgery within three months prior to randomization.
- •Cardiac resynchronization therapy within three months prior to randomization.
- •Cardioversion within three months prior to randomization
- •Transcatheter aortic valve implantation within three months prior to randomization
- •Need for any cardiovascular surgery (including registration on cardiac transplant list).
- •Coronary angioplasty within one month prior to randomization.
- •Previous surgical mitral valve repair.
- •Renal replacement therapy.
- •Active infection requiring current antibiotic therapy.
- •Severe hepatic insufficiency.
- •Stroke within three months prior to randomization.
- •Concurrent medical condition with a life expectancy of less than 12 months.
- •Uncontrolled arterial hypertension.
- •Hypersensitivity to nitinol.
- •Participation to another trial.
- •Pregnancy.
- •No affiliation to a health insurance system.
- •Legal protection measure (guardianship or curatorship)
研究组 & 干预措施
MitraClip Device
Experimental
Subjects randomized to the MitraClip Device group will undergo the MitraClip procedure in addition to optimal standard medical therapy.
干预措施: Percutaneous MitraClip Device Implantation (Device)
Control
Other
Patients randomized to the Control group will receive optimal therapy alone
干预措施: control (Other)
结局指标
主要结局
All-cause mortality and unplanned hospitalizations for heart failure
时间窗: 1 year
次要结局
- Change in Quality of Life score as measured by the European Quality of Life-5 Dimensions instrument.(6 months and 12 months)
- Change in echocardiographic evaluation between baseline at 6, 12 and 24 months.(6 months, 12 months and 24 months)
- Change in functional evaluation(12 months)
- Cost-effectiveness of each strategy at 12 months(12 months)
- Serious Adverse Events(30 days, 6 months, 12 months and 24 months.)
- All-cause mortality, cardiac mortality(30 days, 6 months, 12 months, and 24 months.)
- Survival with no major cardiovascular events(30 days, 6 months, 12 months, and 24 months.)
- Change in biomarkers (BNP levels, creatinine) at 6 months and 12 months(6 months and 12 months)
研究者
研究点 (71)
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