Perioperative MAnaGement of patieNts With Cardiac Implantable Electronic Devices: Randomized Controlled Pilot Trial (MAGNET Trial)
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Any inappropriate sensing of EMI caused by electrocautery.
研究概览
简要总结
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these patients. Depending on the device type and patient's dependency, these guidelines recommend the intraoperative magnet use, reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable method) has become the standard approach in many centers, while CIED reprograming by trained personnel is required in most centers. Therefore, our objective is to compare in a prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS reprogramming vs. no intervention (in the appropriate subjects)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •All subjects with cardiac implanted electronic device (CIED) who are candidates of non-cardio-thoracic surgery or endoscopy and anticipated use of electrocautery
排除标准
- •Recent CIED implantation (less than 6 weeks)
- •Subjects with ICD who are pacemaker dependent
- •Cardio - thoracic surgery
- •Surgery over the CIED site
- •Surgery site that preclude use of magnet in efficient way
- •Subjects with Implanted unipolar leads
结局指标
主要结局
Any inappropriate sensing of EMI caused by electrocautery.
时间窗: DURING SURGERY/PROCEDURE
次要结局
- Any significant change in CIEDS parameters(WITHIN 1 DAY OF SURGERY/PROCEDURE)
研究者
Mahmoud Suleiman MD
MD
Rambam Health Care Campus
