ICD-ON Registry: Periop Management of Cardiac Devices

Completed

• Conditions: Oversensing Cardiac Pacemaker; ICD; Surgery

• Registration Number: NCT02052453
• Lead Sponsor: Edward Hospital

Brief Summary

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.

Detailed 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) 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.

Study Timeline

• Study First Submitted: 2014-01-30
• Study First Submitted QC: 2014-01-31
• Study Start: 2014-02
• Study First Posted: 2014-02-03
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2017-07-26
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of EMI.	up to 90 days	Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.

Secondary Outcome Measures

Name	Time	Method
Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.	up to 90 days	Percentage of patients with pacing inhibition recorded intraoperative or on postoperative electrograms during time of electrocautery.

Trial Locations

Locations (3)

Edward Hospital; 🇺🇸 Naperville, Illinois, United States

Advocate Good Samaritan Hospital; 🇺🇸 Downers Grove, Illinois, United States

Elmhurst Hospital; 🇺🇸 Elmhurst, Illinois, United States