NCT01109641已完成4 期
PhrenIc Nerve mappinG and Stimulation EP Catheter Study: PING-EP Study
Medtronic Italia8 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 8
- 主要终点
- Effect of electrode property on phrenic nerve stimulation (PNS)
研究概览
简要总结
The PING-EP study is designed to evaluate electrode properties on phrenic nerve stimulation (PNS) in coronary sinus using a commercially available diagnostic electrophysiology catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject is indicated for a cardiac resynchronization therapy-pacemaker or defibrillator (CRT-P/CRT-D) implant, for an upgrading from a previously implanted single/dual chamber pacemaker/implantable cardioverter (ICD) or for system revision requiring repositioning of the transvenous left ventricular (LV) lead
- •Patient has signed and dated the study-specific Patient Informed Consent form
- •Subject is at least 18 years of age
排除标准
- •Patient has a previous LV lead implanted not requiring repositioning
- •Pregnant woman
- •Patient is enrolled or planning to participate in any concurrent study, which would confound the results of this trial as determined by Medtronic, during the course of this clinical study
结局指标
主要结局
Effect of electrode property on phrenic nerve stimulation (PNS)
时间窗: at implant
Effect of electrode property on PNS in the cardiac veins
次要结局
- Effect of electrode configuration on phrenic nerve stimulation (PNS)(at implant)
- Electrode polarity effect on phrenic nerve stimulation (PNS)(at implant)
- Effect of electrode property on sensing (r-wave amplitude)(at implant)
- Incidence of phrenic nerve stimulation (PNS) in the cardiac veins(at implant)
研究者
研究点 (8)
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