NCT02247427已完成2 期
Midterm Clinical Outcomes Related to Cardiac Resynchronization Therapy Deactivation of Super Responders
Yuksek Ihtisas Hospital0 个研究点目标入组 19 人开始时间: 2009年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 主要终点
- Clinical/Echocardiographic outcome
研究概览
简要总结
The purpose of this study is to determine clinical outcomes related to deactivation of Cardiac Resynchronization Therapy device in subjects with super response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •super response to Cardiac Resynchronization Therapy
- •near normal Left ventricular ejection fraction
- •>99% pacing
排除标准
- •<99% pacing
- •atrial fibrillation
- •ischemic cardiomyopathy
研究组 & 干预措施
Off-pace group
Experimental
Deactivated device group
干预措施: Cardiac Resynchronization Therapy Device (Device)
On-Pace group
No Intervention
Ongoing device activity group
结局指标
主要结局
Clinical/Echocardiographic outcome
时间窗: 12 months
Clinical/Echocardiographic outcome including New York Heart Association class, 6-min walk test, Left ventricular ejection fraction, Left ventricular end- diastolic diameter, Left ventricular end-systolic volume, and Left ventricular end-systolic diameter.
次要结局
- Mortality(12 months)
- Heart failure hospitalization(12 months)
- Cardiac Resynchronization Therapy Device intervention(12 months)
研究者
Serkan Cay
Associate Professor
Yuksek Ihtisas Hospital
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