Mapping for Acute Transvenous Phrenic Nerve Stimulation Study (MAPS Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)
研究概览
简要总结
The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.
详细描述
Purpose The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an EP catheter advanced into the great veins.
Study Design This is a prospective, non-randomized, acute feasibility study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects older than 18 years of age
- •Subject is undergoing a cardiac catheterization involving right heart catheterization and/or EP procedures and/or device implant.
- •Subjects willing and able to give informed consent
排除标准
- •Subject with a previously implanted transvenous lead, which is still present in the veins under study.
- •Subject with evidence of phrenic nerve palsy.
- •Subject with chronic obstructive pulmonary disease.
- •Subject with a spinal cord stimulator.
- •Subject needs to receive drugs that might interfere with patient perception.
- •Subjects with medical conditions that would prevent study participation
- •Subjects who are pregnant, nursing, or of child bearing potential and are not on a reliable form of birth control
- •Subjects enrolled in concurrent studies which could confound the results of this study
- •Subject is unable or unwilling to participate with study procedures
结局指标
主要结局
Number of Patients With Response to Stimulation (Diaphragmatic Movement Achieved)
时间窗: one hour
Number of Patients With Response to Stimulation, defined by Presence of Movement of the Diaphragm Induced by a Pacing Stimulus With Pulse Amplitude of 10 V or Less
次要结局
- Number of Patients With Response to Stimulation (Tidal Volume)(one hour)
- Number of Patients With Observed Side Effects(From procedure to 2-4 weeks post-procedure)
- Number of Observed Side Effects(From procedure to 2-4 weeks post-procedure)