Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Absence of device related or procedure related adverse events
研究概览
简要总结
Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.
详细描述
This study is being conducted to determine if in an anaesthetized (sedated, intubated and mechanically ventilated) subject the LIVE Catheter can be inserted percutaneously and activated via the electrical stimulator to stimulate the left and right phrenic nerves causing the diaphragm to contract in synchrony with mechanical ventilator breaths via phrenic nerve stimulation from a transvenously delivered electrical current.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
- •Able to undergo general anaesthesia (sedation, intubation and mechanical ventilation)
- •Susceptible indication for atrial septal defect closure
排除标准
- •Subject has an EF of < 30%
- •Subject has a co-morbid illness or life expectancy < 2 years
- •Subject has experienced an AMI within 72 hours prior to this procedure
- •Subject is contraindicated for or unwilling to take aspirin or anticoagulants
- •Subject is in cardiogenic shock
- •Subject has other cardiovascular disease requiring open heart surgery
- •Subject is known to have a demonstrated intra cardiac thrombus on echocardiography
- •Subject has been treated with paralytic medications within 72 hours prior to procedure
- •Subject has significant thoracic abnormalities such that placement of a left subclavian line would be difficult
- •Inability to cannulate the left subclavian vein (post-consent exclusion)
- •Subject has a known or suspected phrenic nerve paralysis
- •Subject has co-existing temporary or implanted cardiac electrical devices such as a pacemaker or defibrillator
- •Subject has an active systemic infection or local infection at or around the insertion site
- •Subject is known or suspected to be pregnant or is lactating
- •Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol
- •Subject is currently enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
结局指标
主要结局
Absence of device related or procedure related adverse events
时间窗: up to 48 hours or at time of discharge whichever comes first
Assess subject AE status out to 48 hours post procedure
Successful insertion of the LIVE Catheter into the left subclavian vien
时间窗: at time of procedure
Confirmation by cinefluoroscopy of the insertion of the LIVE Catheter into the Left subclavian vein with the tip located in the superior vena cava
次要结局
- Phrenic nerve stimulation in synchrony with MV breaths(No more than 90 minutes procedure duration)