NCT03438591已完成不适用
The Effect of "Cerclage Pacing" for the Heart Failure Patients Who Need Cardiac Resynchronization Therapy (CRT): Early Feasibility Study
Tau Pnu Medical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年3月5日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- rate of procedural success
研究概览
简要总结
trans-coronary sinus intraseptal pacing (cerclage pacing)
详细描述
This study is aimed at looking at the effect of "Cerclage pacing" for the heart failure patients who need cardiac resynchronization therapy (CRT). The study hypothesis is that parahisian pacing by 'cerclage pacing' may have a similar benefit as is seen with permanent Hisian pacing
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who need cardiac resynchronization therapy (CRT) or CRT-non responder
- •Left bundle branch block [LBBB]) > 120ms of QRS width
- •Ejection fraction (EF) < 35%
- •NYHA class III-IV in spite of optimal medical Tx
排除标准
- •Unsuitable coronary vein anatomy on cardiac CT
- •Subjects with prosthetic mechanical tricuspid valve
- •Active infection
- •Life expectancy less than 6 months
研究组 & 干预措施
Cerclage-CRT (medtronic 4196 lead)
Experimental
trans-coronary sinus intraseptal pacing (cerclage pacing) which technology to position the pacemaker lead into the septum for 'parahisian pacing'
干预措施: Medtronic 4196 lead (Device)
结局指标
主要结局
rate of procedural success
时间窗: immediate postprocedure
Narrowing QRS by 20% or greater compared with baseline QRS width
次要结局
- interrogation index of pacemaker lead(12 months)
- Change in subjects' symptoms referred to NYHA Classification System(12 months)
- Change in subjects' improvement of parameters by Echocardiography(12 months)
- Change of Six minute walk Distance(12 months)
研究者
June-Hong Kim, MD, PhD
Professor
Pusan National University Yangsan Hospital
研究点 (1)
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