NCT03035227终止4 期
Catheter Ablation of Arrhythmias to Improve CRT Response
Kansas City Heart Rhythm Institute1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2017年1月23日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Ejection Fraction (EF)
研究概览
简要总结
The purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Heart failure patients with CRT-D or CRT-P greater than 3 months
- •Bi-ventricular pacing less than 94% of the time
- •3 months after CRT-D or CRT-P implantation an EF improvement less than 5%
- •Presence of one of the following arrhythmias and eligible for catheter ablation:
- •Atrial fibrillation
- •Atrial flutter
- •Supraventricular tachycardia
- •Premature ventricular contraction burden greater than 30% in a 24-hour period
- •Ventricular tachycardia
排除标准
- •Estimated survival less than one year
- •Patient unable to make scheduled follow up visits at treating center
- •Participating in another investigational study
研究组 & 干预措施
Catheter Ablation
Active Comparator
Catheter ablation procedure of atrial and/or ventricular arrhythmias.
干预措施: Catheter Ablation (Procedure)
Medical Therapy
Active Comparator
Medical management using antiarrhythmic drugs per standard of care of treating physician.
干预措施: Anti-Arrhythmics (Drug)
结局指标
主要结局
Change in Ejection Fraction (EF)
时间窗: 90 Days
Change in Ejection Fraction (EF)
Bi-ventricular Pacing Improvement
时间窗: 90 Days
data not analyzed
Cardiovascular Mortality
时间窗: 365Days
data not analyzed
次要结局
- All-cause Mortality(365 Days)
- Hospital Admissions for Heart Failure Exacerbation(365 Days)
- New York Heart Association (NYHA) Class Change(30 Days)
- Change in 6 Minute Walk Test(30 Days)
- Change in Quality of Life - SF-36(30 Days)
- Change in Quality of Life Kansas City Cardiomyopathy Questionnaire (KCCQ)(30 Days)
研究者
研究点 (1)
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