RELIVE (Randomized Evaluation of Less Invasive Ventricular Enhancement) Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Composite Effectiveness Endpoint
研究概览
简要总结
A prospective, multi-center randomized trial comparing the Revivent System plus GDMT to GDMT alone. A total of approximately 135 subjects will be randomized in a 2:1 allocation ratio (90 treatment and 45 control), with approximately 128 evaluable patients and assuming 5% loss to follow-up. A primary safety endpoint will be evaluated at 30 days. Primary efficacy endpoint will be at 1 year. Interim efficacy endpoints will be evaluated at 6 months.
详细描述
The purpose of the study is to assess the safety and effectiveness of the BioVentrix Revivent System plus GDMT compared to GDMT alone for the treatment of LV anterior/apical scar/aneurysm with possible additional involvement of the lateral, septal, and/or inferior regions in patients with symptomatic heart failure.
Safety will be assessed compared with a Performance Goal based on surgical ventriculoplasty outcomes (MAE's at 30 days).
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
- •18 years old or older
- •LV Aneurysm or Scar Presence: Defined by presence of a contiguous acontractile (akinetic and/or dyskinetic) non-calcified scar
- •LV Aneurysm/Scar Location: Defined as a scar involving anterior, apical or anterolateral ± septal regions of the left ventricle as evidenced by cardiac imaging (Viability of myocardium in regions remote from area of intended scar exclusion as evidenced by cardiac imaging)
- •Left Ventricular Ejection Fraction < 40%
- •Left ventricular end-systolic volume index ≥60 mL/m2
- •Suffering from heart failure symptoms as defined by NYHA Classification > 2 not responsive to medical therapy
- •Patient completed 6 Minute Walk Test and KCCQ Quality of Life Questionnaire (can be performed at baseline visit)
- •Patient is on adequate Guideline Directed Medical Therapy (GDMT)
- •Subject or a legally authorized representative must provide written informed consent
- •Agree to required follow-up visits
- •Female subject of childbearing potential does not plan pregnancy for at least one year following the index procedure. For a female of childbearing potential, a pregnancy test must be performed with negative results known within seven days prior to index procedure
排除标准
- •Candidates will be excluded from the study if ANY of the following conditions is present:
- •Cardiac Resynchronization Therapy (CRT) or ICD pacing lead placement ≤ 90 days prior to enrollment
- •Valvular heart disease, which in the opinion of the investigator, will require intervention (transcatheter or surgical)
- •Mitral Regurgitation greater than moderate (>2+)
- •Need for coronary revascularization, in the opinion of the investigator
- •Peak Systolic Pulmonary Arterial Pressure > 70 mm Hg via echo or right heart catheterization
- •Myocardial Infarction within 90 days prior to enrollment
- •Within the last six months, a prior CVA or TIA, or intracranial hemorrhage
- •Co-morbid disease process with life expectancy of less than one year or active malignancy not in remission
- •Severe pulmonary disease that would preclude general anesthesia
- •Any solid organ transplant or is on waiting list for any solid organ transplant other than cardiac
- •Chronic renal failure with a GFR<30ml/min
- •Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
研究组 & 干预措施
Guideline Directed Medical Therapy (GDMT) only
Subjects would remain on Guideline Directed Medical Therapy (GDMT) with no additional medical intervention.
Revivent System Therapy plus Guideline Directed Medical Therapy (GDMT)
Medical Intervention through a mini thoracotomy, placement of anchors to plicate the scarred areas of the heart thereby reducing the left ventricle size and improving left ventricle mechanics. Subjects would continue on Guideline Directed Medical Therapy (GDMT)
干预措施: Revivent System (Device)
结局指标
主要结局
Composite Effectiveness Endpoint
时间窗: 6 Months
Using Finkelstein Schoenfeld (FS) hierarchical approach. This approach compares each treatment subject versus each control subject in a hierarchal fashion beginning with Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio.
Major Adverse Events Composite Performance Goal
时间窗: 30 days
Composite of Major Adverse Events at 30 days comprised of Clinical Events Committee (CEC) Adjudication of Mortality, Myocardial Infarction (MI), Major Stroke, Prolonged Intubation \>48hrs, Need for Inotropic support \>24hrs, Mech circulatory support intra or post op, BARC 4 or 5 bleeding, reoperation, serious infection related to device or procedure, Cardiac tamponade, or Initiation of renal replacement therapy, with a Performance Goal (PG) of 70% (upper bound of the 97.5% one sided CI)
Composite Effectiveness Endpoint
时间窗: 12 Months
Using Finkelstein Schoenfeld (FS) hierarchical approach - Cardiovascular Mortality, Heart Transplant, Left Ventricular Assist Device (LVAD) Implantation, Hospital Readmission, Kansas City Cardiomyopathy Questionnaire (+10 point improvement with higher score being better), 6 Minute Walk Test (+25meter improvement with longer distance being better), change in New York Heart Association (NYHA) Class (+1 point improvement with scale being 1 to 4 with lower value being better). Begin comparing at highest hierarchal assessment. If one group is "better than" the other, count as "win". If treatment and control subject equal at that assessment, compare to next hierarchal measure, if equal again, go to next until you have a "win". Compare overall wins versus loses for an overall win ratio.
次要结局
未报告次要终点