Recruitment

Recruitment Status
Completed

Exclusion Criterias

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

Summary

Conditions
  • ICD
  • Oversensing Cardiac Pacemaker
  • Surgery
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

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) ...

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.

Exclusion Criterias

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

Locations

Downers Grove, Illinois, 60515
Naperville, Illinois, 60174
Elmhurst, Illinois, 60126
Downers Grove, Illinois, 60515
Naperville, Illinois, 60174
Elmhurst, Illinois, 60126

Tracking Information

NCT #
NCT02052453
Collaborators
  • Medtronic
  • Abbott Medical Devices
  • Boston Scientific Corporation
Investigators
  • Principal Investigator: Janet Gifford, MSN, NP Edward Hospital
  • Janet Gifford, MSN, NP Edward Hospital