NCT00846001已完成3 期
Study of Resynchronization and CABG Unified Efficacy in Ischemic Heart Failure Patients
Meshalkin Research Institute of Pathology of Circulation4 个研究点 分布在 3 个国家目标入组 178 人开始时间: 2007年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 178
- 试验地点
- 4
- 主要终点
- Long-term mortality
研究概览
简要总结
The purpose of the study is to compare survivability and efficacy of the patients with severe ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass grafting with single-step implantation of CRT system (CABG alone vs CABG + CRT )
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •Age 18-80
- •History of ischemic heart failure and indications for CABG
- •LVEF less than 35% estimated by echocardiography measured within 3 months of study entry
- •NYHA and CCS (angina) II-IV functional class
- •Signs of dyssynchrony (at least one of the following three): QRS > 120 ms or dyssynchrony based on Doppler-methods (Tissue Tracking and TSI methods) or CARE HF criteria: Aortic pre-ejection delay >140ms, Interventricular mechanical delay >40 ms, Delayed activation of postero-lateral LV wall
排除标准
- •Failure to provide informed consent.
- •Previous cardiac surgery
- •Non-cardiac illness with a life expectancy of less than 3 year
- •Non-cardiac illness imposing substantial operative mortality
- •Previous heart, kidney, liver, or lung transplantation
- •Current participation in another clinical trial in which a patient is taking an investigational drug or receiving an investigational medical device
- •Successful coronary revascularization (СABG or PCI) within 12 months of study enrollment
- •Chronic atrial fibrillation
结局指标
主要结局
Long-term mortality
时间窗: 6 years
次要结局
- Mode of Death(6 years)
- Adverse cardiac events(6 years)
- Lead performance(6 years)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
4 期
Clinical Evaluation on Advanced ResynchronizationHeart FailureCardiomyopathyNCT00658203LivaNova310
已完成
4 期
Spanish Atrial Fibrillation And Resynchronization StudyCardiomyopathy, DilatedAtrial FibrillationChronic Heart FailureNCT01181414Hospital Clinic of Barcelona60
已完成
不适用
Cardiac Resynchronization Therapy Efficacy EnhancementsAtrial FibrillationNCT02222818Medtronic Cardiac Rhythm and Heart Failure71
已完成
不适用
Cardiac Resynchronization Therapy (CRT) Efficacy StudyHeart FailureNCT00822146Medtronic Cardiac Rhythm and Heart Failure9
尚未招募
不适用
Efficacy and Safety of Synchronized Cardiac Support in Cardiogenic Shock PatientsExtracorporeal Membrane OxygenationECLSVA ECMOCardiogenic ShockNCT05106491Xenios AG21