A Prospective, Multicenter, Randomized Controlled Clinical Study to Evaluate the Safety and Effectiveness of the DragonFly Transcatheter Mitral Valve Clip System in the Treatment of Moderate-to-Severe or Severe Functional Mitral Regurgitation (FMR)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Clinical success at 12 months after the procedure
研究概览
简要总结
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.
详细描述
This study is a prospective, multicenter, randomized controlled design. Patients are chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects in the experimental group will undergo the transcatheter mitral valve repair procedure using the DragonFly™ Transcatheter Mitral Valve Clip System . According to the investigator's discretion, all subjects in the treatment group will continue to receive maximally tolerated guideline-directed medical therapy (GDMT). Subjects in the control group will also continue maximally tolerated GDMT as determined by the investigator. After completing the 12-month follow-up, crossover to the treatment group will be permitted.
All subjects were followed up before discharge (excluding the control group), and 30 days, 6 months, 12 months, and 24 months after treatment. Subjects in the experimental group and those who crossed over to the experimental group underwent extended clinical follow-up for 3, 4, and 5 years.
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
- Single (Outcomes Assessor)
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
- •1) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy
- •Transseptal catheterization and femoral vein access is determined to be feasible.
- •The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.
排除标准
- •1) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2）Echocardiography revealed severe restriction of leaflet motion due to tethering.
- •3) The presence of other severe heart valve disease requiring surgical intervention.
- •Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- •In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.
研究组 & 干预措施
Randomized - Device Group
This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
干预措施: DragonFly System (Device)
Randomized - Device Group
This group is allocated to use DragonFly System for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd.
干预措施: Drug (Drug)
Randomized - Control Group
This group will continue to be managed on medical therapy, per physician discretion
干预措施: DragonFly System (Device)
Randomized - Control Group
This group will continue to be managed on medical therapy, per physician discretion
干预措施: Drug (Drug)
结局指标
主要结局
Clinical success at 12 months after the procedure
时间窗: 12 months
The rate of the composite endpoint of freedom from all-cause mortality, hospitalization for heart failure, NYHA improved \<1 class and MR \> 2+ at 12 months.
次要结局
- Mitral regurgitation severity(30 days, 6 months, 12 months)
- Recurrent heart failure (HF) hospitalizations(30 days, 6 months, 12 months)
- NYHA Class(30 days, 6 months, and 12 months)
- Change in 6 minutes walk test distance(12 months)
- Quality of life improvement(12 months)
- Left Ventricular End Diastolic Volume (LVEDV)(12 months)
- Acute procedural success（only for experimental group）(Immediately after procedure, Discharge: The day after the patient's exit from the cardiac catheterization laboratory)
- Acute device success（only for experimental group）(Immediately after procedure)