Electrical Signal Collection From a 20 Pole Catheter During Routine Cardiac Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- The electrical signal mean amplitude (mv) during AV synchronous pacing.
研究概览
简要总结
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.
详细描述
The purpose of this study is to collect atrio-ventricular electrograms using a sequence of tip-ring spacings in patients undergoing routine cardiac procedures (EP study, pacemaker/ICD/CRT implant). To collect these signals, a 20 pole catheter (Medtronic StableMapr intracardiac steerable electrode catheter) will be acutely placed in the RV apex during a routine cardiac procedure.
Routine data collection will be conducted during normal sinus rhythm and AV synchronous pacing for approximately 20 minutes. The data collected will then be processed and the P, R and T wave amplitudes will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subjects aged 18 or above, or of legal age to give consent specific to the national law of the countries in which the study is being conducted
- •Subjects who are undergoing a cardiac procedure where routine placement of cardiac catheter can be performed
- •Subjects are willing to provide Informed Consent
排除标准
- •• Subject has exclusion criteria per local law and regulations (e.g. age, breast feeding, etc)
- •Any condition which precludes the subject's ability to comply with the study requirements
- •Subject has physical conditions that contraindicate the use of the device per approved labeling, including but not limited to active sepsis, known sensitivity to heparin, cannot undergo standard anticoagulation protocol for cardiac procedure, blood clotting abnormalities or a recent coagulopathy or embolic event, venous filtering device (Greenfield Filter) and obstructed or damaged vessel
研究组 & 干预措施
Intracardiac electrode catheter
All patient in the study will have same data collected during the procedure using the Steerable intracardiac electrode catheter.
干预措施: Intracardiac electrode catheter (Other)
结局指标
主要结局
The electrical signal mean amplitude (mv) during AV synchronous pacing.
时间窗: 2 minutes during the procedure
次要结局
未报告次要终点