Annular ReduCtion for Transcatheter Treatment of Insufficient Mitral ValvE (ACTIVE): A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Assess Transcatheter Mitral Valve Repair With Edwards Cardioband System and GDMT vs GDMT Alone in Patients With FMR and Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 24
- 主要终点
- Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].
研究概览
简要总结
To establish the safety and effectiveness of the Edwards Cardioband System in patients with functional mitral regurgitation (FMR).
详细描述
The ACTIVE Trial is a prospective, randomized, multicenter trial. Patients with clinically significant functional mitral regurgitation will be randomized 2:1 to receive either transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT) or GDMT alone. Patients will be seen for follow-up visits at discharge, 30 days, 6 months, and annually through 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
- 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;
- •Clinically Significant Functional Mitral Regurgitation (MR);
- •Symptomatic heart failure;
- •Patient hospitalized due to heart failure during 12 months prior to submission to Central Screening Committee OR elevated Brain Natriuretic Peptid (BNP);
- •Patient is able and willing to give informed consent and follow protocol procedures, and comply with follow-up visit compliance.
排除标准
- •Primarily degenerative MR;
- •Mitral annular calcification that would impede implantation of device;
- •Other severe valve disorders requiring intervention;
- •Mitral valve anatomy which may preclude proper Edwards Cardioband deployment;
- •Life expectancy of less than twelve months;
- •Patient is participating in concomitant research studies of investigational products which have not reached their primary endpoint;
- •Unwillingness or inability to undergo follow-up investigations/visits;
- •Other medical, social, or psychological conditions that precludes appropriate consent and follow-up
研究组 & 干预措施
Randomized - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
干预措施: Edwards Cardioband System (Device)
Randomized - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
干预措施: Guideline Directed Medical Therapy (Drug)
Randomized - Control
Guideline directed medical therapy (GDMT)
干预措施: Guideline Directed Medical Therapy (Drug)
Roll-In - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
干预措施: Edwards Cardioband System (Device)
Roll-In - Edwards Cardioband System
Transcatheter mitral valve repair with the Edwards Cardioband System plus guideline directed medical therapy (GDMT)
干预措施: Guideline Directed Medical Therapy (Drug)
结局指标
主要结局
Prevalence of MR ≤ 2+ and Hierarchical Comparison of Randomized Device and Randomized Control Groups [Cardiovascular Death, Number of Heart Failure Hospitalizations, Improvement in 6 MWT Distance (in Meters) and KCCQ (Number of Points Improved)].
时间窗: 1 year
Hierarchical comparison of device and control groups (for randomized groups): MR ≤ 2+ and cardiovascular death, number of heart failure hospitalizations, improvement in 6 MWT distance (in meters) and KCCQ (number of points improved).
Number of Participants With Major Adverse Events (MAE) [Device Group Only]
时间窗: 30 days
Overall rate of device and procedure related Major Adverse Events (MAEs) through 30 days post procedure (including death, stroke, myocardial infarction, pericardial effusion requiring drainage, left circumflex coronary artery injury requiring intervention, mitral valve reintervention, and access site and vascular complications requiring intervention
次要结局
- Secondary Endpoints Through 1 Year (Powered for Randomized Arms Only)(1 year)
- Device Success(30 days)
- Procedural Success(30 days)
- Clinical Success(30 days)
- Secondary Safety Endpoints [Device Group Only](30 days)