Noninferiority Trial of MitraClip Implantation Strategies: 1 Clip vs. 2 Clips in Patients With Functional Mitral Regurgitation (One-Plus-One)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Evaluation of number of participants who died death within one year
研究概览
简要总结
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.
详细描述
Implantation of the MitraClip has become the most frequently used percutaneous technique to treat significant (grade 3+ or 4+) mitral regurgitation (MR) in elderly patients deemed inoperable or at high surgical risk. In Europe, about two-thirds of patients treated with the MitraClip suffer from MR of functional origin secondary to ischemic or dilated cardiomyopathy. At present, there is debate among operators on whether stabilizing/supporting a single adequately implanted clip with a second clip is beneficial for patients with functional MR.
Purpose To demonstrate the noninferiority of a 1-clip strategy vs. a 2-clip strategy of MitraClip implantation, when the second clip in the 2-clip study arm is implanted for stabilizing/supporting purposes.
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
- •Absence of a structural abnormality of the mitral valve giving rise to MR.
- •MR severity of US grade 3+ or 4+ of central or noncentral origin
- •Patient must consent to randomization in the hybrid operating theater upon successful implantation of a single MitraClip. Written informed consent must be provided prior to the MitraClip procedure.
排除标准
- •patients with primary regurgitation
研究组 & 干预措施
One CLIP
Implantation of single MitraClip
干预措施: MitraClip implantation (Device)
Two CLIPs
Implantation of second MitraClip (after successful Implantation of single MitraClip)
干预措施: MitraClip implantation (Device)
结局指标
主要结局
Evaluation of number of participants who died death within one year
时间窗: 1 year
death
Evaluation of number of rehospitalizations due to heart failure among patients receiving one or two clips
时间窗: 1 year
heart failure rehospitalization
Evaluation of number of participants with recurrent regurgitation within one year
时间窗: 1 year
recurrence of mitral regurgitation (\>grade 2+ at 1 year)
次要结局
- heart failure(1 year)
- total device time(1-year)
- NYHA(1-year)
- 6-minutes walk(1-year)
- fluoroscopy time(1-year)
- changes in echocardiographic variables(1-year)
- quality of life(1-year)
- rehospitalization(1-year)
- regurgitation(1-year)
- contrast volume(1-year)
- death(1 year)
- success rate(1-year)
- procedure duration(1-year)
- complications(1-year)
- echocardiographic variables(1-year)