跳至主要内容
临床试验/NCT02025738
NCT02025738Unknown不适用

Perioperative MAnaGement of patieNts With Cardiac Implantable Electronic Devices: Randomized Controlled Pilot Trial (MAGNET Trial)

Rambam Health Care Campus2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Suleiman MD

MD

Rambam Health Care Campus

研究点 (2)

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