CTRI/2016/08/007165已完成4 期
A clinical study for the safety and effectiveness of Dual Chamber Rate Responsive Implantable Pacemaker model CHARAK 747R.
Shree Pacetronix Ltd0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1.Fixed (third degree) AV block
- •2.Atrial Fibrillation with average Ventricular rate on ECG equal or less than than 40bpm or mean heart rate equal or less than 60bpm.
- •3.Sinus node Dysfunction with PR interval equal or greater than 300msec
- •4.Paroxysmal, persistent or permanent AF undergoing AV node , AV node/HIS ablation
- •5.2°AV Block with equal or greater than 3:1 block
- •6.The subject is 18 years of age or older
- •7.The subject has provided written consent for the Pacemaker procedure.
- •8.Pre-existing Cardiac Permanent pacemaker showing â??Beginning of Lifeâ??.
排除标准
- •1.Pre-existing permanent cardiac pacemaker or ICD (defibrillator)
- •2.Presence of Hypertrophic Obstructive Cardiomyopathy
- •3.Recent cardiac surgery (equal or less than 30 days)
- •4.Recent myocardial infarction (equal or less than 30 days)
- •5.Presence of mechanical prosthetic tricuspid valve
- •6.Current or planned pregnancy in the next 6 months.
- •7.Patients with life expectancy less than 6 months.
- •8.chronic renal failure
研究者
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