NCT01512381终止4 期
Variant of Stimulation in Atrioventricular Node Ablation (VISTA) in Patients With Atrial Fibrillation and Moderate Chronic Heart Failure
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2010年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Left Ventricle End-Systolic Volume (LV ESV)
研究概览
简要总结
The purpose of this study is to determine whether cardiac resynchronization therapy (CRT) is superior to interventricular right ventricle (RV) septal pacing in respect of reverse remodeling (LV ESD) and morbidity in patients with less preserved (less than 45%) ejection fraction (EF), persistent/permanent atrial fibrillation (AF) who successfully received atrioventricular (AV) junction ablation ablation (100% pacemaker dependency)
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-75 years
- •CHF II-III NYHA
- •Persistent/permanent AF requiring AV node ablation
- •LVEF < 45%
- •Signed informed consent
- •Able to complete all testing required by the clinical protocol
排除标准
- •Myocardial infarction or stroke less than 3 months prior to randomization
- •Patients who require revascularization, radiofrequency ablation of pulmonary veins and substrate of AF
- •The congenital and acquired heart diseases, LV aneurysm, which requires a surgical correction
- •Active inflammatory and autoimmune diseases of a myocardium
- •The thyrotoxicosis
- •The diseases that limit life expectancy (cancer, tuberculosis, etc.)
- •Contraindications to anticoagulants administration at CHADS2> 2
- •Uncompliant patients
研究组 & 干预措施
CRT
Experimental
干预措施: Implantation of CRT device (Device)
pacemaker
Active Comparator
干预措施: Implantation of conventional VVI(R) pacemaker (Device)
结局指标
主要结局
Left Ventricle End-Systolic Volume (LV ESV)
时间窗: 12 months
次要结局
- Echocardiographic indexes of LV remodeling(12 months)
- Changes in NYHA functional class measured by peak V O2 oxygen consumption and distance of 6-minute walk test(12 months)
- Changes in Quality of Life (measured by Minnesota Living with Heart Failure Questionnaire)(12 months)
- Rate of cardiovascular events (hospitalization for worsening heart failure)(12 month)
研究者
研究点 (2)
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