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Completed

NCT Number: NCT02052453

ICD-ON Registry: Periop Management of Cardiac Devices

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advocate Good Samaritan Hospital, Downers Grove, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Have a implanted PM or ICD
  • Be scheduled for a procedure with anticipated electrocautery
  • Be able to speak, read and understand English
  • Be willing to sign consent form

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Incidence of EMI.

    Time frame: up to 90 days

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

Secondary outcomes

  1. Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.

    Time frame: up to 90 days

    Percentage of patients with pacing inhibition recorded intraoperative or on postoperative electrograms during time of electrocautery.

Other outcomes

  1. Incidence of device reset.

    Time frame: up to 90 days

    Percentage of total patients enrolled with device reset requiring reprogramming on their first postoperative interrogation. Either immediately postoperative for reprogramming group, in office or remote for all others.

Sponsors and collaborators

Lead sponsor

Edward Hospital

Other

Collaborators

  • Abbott Medical Devices
  • Boston Scientific Corporation
  • Medtronic

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 3, 2014
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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