Use of Transvenous Pacing Wire During Minimally Invasive Port Access Aortic Valve Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 主要终点
- Number of Participants That Required Pacing Who Were Able to be Paced
研究概览
简要总结
The study is being done to determine if the Endovent pulmonary catheter kit, used for port access surgery, can be used as a passageway for a pacing wire. The study hypothesis is that the Endovent kit can be used effectively as a passageway for a pacing wire system.
详细描述
Many times cardiac surgery requires the use of epicardial pacing in order to wean the patient from bypass. During minimally invasive port access valve surgery, it may not be possible to place the leads on the surface of the heart because of the limited surgical exposure. In this case, transvenous pacing is used. Minimally invasive port access surgery uses specially designed, FDA approved catheters for the procedure. We wish to review the effectiveness of being able to place the wires through the catheters and pace the patient.
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
- •>= 18 years of age patients having aortic valve port access surgery
- •Scheduled for Minimally Invasive Port Access Aortic Valve Study
- •Patient must agree to study participation; understand and sign the written informed consent
排除标准
- •< 18 years of age Patients are excluded if they are not having minimaly invasive aortic valve surgery not having aortic valve port access surgery
结局指标
主要结局
Number of Participants That Required Pacing Who Were Able to be Paced
时间窗: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
To be able to pace the heart post aortic valve replacement surgery
Number of Participants Were the Endovent Pacing Wire Were Able to Obtain a Ventricular Sensing Signal
时间窗: Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.
Heart to begin pacing upon passing the wire through the catheter to the heart. The catheter would be to be able to pace the heart, with 5 or less milliamps, post heart surgery
次要结局
- Number of Participants Who Developed Abnormal Blood Pressure or Heart, and/or Arrhythmias Potentially Related to the Pacing Endovent(Preparing to wean from the cardiopulmonary bypass machine (heart lung machine) until 40 hours post wean.)
研究者
Enrique Pantin
Professor, Department of Anesthesiology
Rutgers, The State University of New Jersey