Randomized Evaluation and Verification of Ventricular Enhancement: The REVIVE-HF Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- 6 Minute Walking Distance
研究概览
简要总结
A prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone.
详细描述
The purpose of the study is to demonstrate that treatment with the BioVentrix Revivent TC System is more effective than guideline directed medical therapy for the treatment of ischemic heart failure. This is a prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the Revivent TC System plus Guideline Directed Medical Therapy (GDMT) compared to GDMT alone. This study will include 180 patients of which 120 patients will be treated with the investigational device and 60 patients will be maintained on GDMT.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased LV systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle.
排除标准
- •Calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities;
- •Inadequate myocardial viability in regions remote from the scar.
- •Thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels;
- •Cardiac Resynchronization Therapy (CRT) consisting of Bi-ventricular pacemaker device (i.e., not ICD only) placement ≤ 60 days prior to treatment;
- •Patient intolerance or unwillingness to take anti-coagulation medication;
- •Functioning pacemaker leads in antero-apical RV, which, in the opinion of the investigator, would interfere with anchor placement;
- •Pulmonary Arterial Pressure > 60 mm Hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy;
- •Myocardial Infarction within 90 days prior to the procedure;
- •Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement;
- •Chronic renal failure with a serum creatinine >2 mg/dL;
- •Inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation.
- •Baseline 6-minute walk distance of >450m
研究组 & 干预措施
Revivent TC Ventricular Enhancement System plus GDMT
Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
干预措施: Revivent TC Ventricular Enhancement System (Device)
Revivent TC Ventricular Enhancement System plus GDMT
Patients will receive treatment with the Revivent TC Ventricular Enhancement System while being maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
干预措施: GDMT (Drug)
GDMT Only
Patients will be maintained on Guideline Directed Medical Therapy for treatment of Heart Failure.
干预措施: GDMT (Drug)
结局指标
主要结局
6 Minute Walking Distance
时间窗: 3 and 6 months after enrollment
Improvement of heart failure symptoms compared to baseline as measured by changes in 6 Minute Walking Distance.
次要结局
- LVESVI and LVEDVI(3 and 6 months after enrollment)
- Quality of Life Index(3 and 6 months after enrollment)
- NYHA Classification(3 and 6 months after enrollment)
- LVEF(3 and 6 months after enrollment)