NCT00187252已完成不适用
Management of Atrial Fibrillation Suppression in AF-HF COmorbidity Therapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Prevalence of permanent atrial fibrillation
研究概览
简要总结
The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting from cardiac resynchronization therapy.
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 (Participant)
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
- •HF patients
- •New York Heart Association (NYHA) III - IV
- •Spontaneous QRS ≥130 ms and/or mechanical interventricular delay > 50 ms
- •Left ventricular ejection fraction (LVEF) ≤ 35%
- •Left ventricular end diastolic diameter (LVEDD) ≥ 55 mm
- •Optimized medical regimen
- •Age > 18 years
排除标准
- •Unstable angina or acute myocardial infarction (MI) (< 3 months)
- •Coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) < 3 months
- •Life expectancy < 6 months
- •Permanent AF
- •Pregnancy
研究组 & 干预措施
1
Experimental
CRT + AF Suppression turned ON
干预措施: Atrial Overdrive Pacing (Device)
2
Active Comparator
CRT + AF Suppression turned OFF
干预措施: Atrial Overdrive Pacing (Device)
结局指标
主要结局
Prevalence of permanent atrial fibrillation
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (2)
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