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临床试验/NCT02052453
NCT02052453已完成不适用

ICD-ON Registry: Perioperative Management of Pacemakers and Implanted Cardioverter Defibrillators

Edward Hospital3 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
3
主要终点
Incidence of EMI.

研究概览

简要总结

The purpose of this registry is to document incidence of electrical magnetic interference (EMI), change in programmed parameters or device related events in patients with Pacemakers (PM) and Implanted Cardioverter Defibrillators (ICDs) having surgery requiring electrocautery. A standardized perioperative device management protocol (ICD-ON Protocol) will be used.

详细描述

Patients with PMs and ICDs have traditionally been considered at risk for electrical magnetic interference (EMI) from electrocautery. EMI can cause oversensing, pacing inhibition, or inappropriate ICD therapies. In July 2011, the Heart Rhythm Society /American Society of Anesthesiologists (HRS/ASA) published an Expert Consensus Statement on the perioperative management of PM and ICDs.

The purpose of this registry is to collect data on patients with PMs and ICDs undergoing procedures requiring electrocautery using a standardized device management protocol (ICD-ON Protocol). Decisions about management of patients with these devices will be made based on surgical location, programmed magnet response and pacemaker dependence.

This registry will document incidence of EMI, changes in programmed parameters or device related events associated with the procedures. Observational data will be collected on participants including: medical history, device parameters, surgical/cautery data, and postoperative device follow-up. For procedures not requiring reprogramming, postoperative PM and ICD interrogation will be either routine in office follow-up or remote monitoring, as per the subject's routine.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 未提供

排除标准

  • Have an ICD from Boston Scientific under Product Advisory related to magnet performance
  • Have an ICD or PM from Biotronik or Sorin
  • Surgical procedures with two or more electrocautery operators.

结局指标

主要结局

Incidence of EMI.

时间窗: up to 90 days

Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.

次要结局

  • Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.(up to 90 days)

研究者

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

Janet Gifford

Nurse Practitioner, Cardiology

Edward-Elmhurst Health System

研究点 (3)

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