ICD-ON Registry: Periop Management of Cardiac Devices
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Exclusion Criteria
- Have an ICD or PM from Biotronik or Sorin
- Surgical procedures with two or more electrocautery operators.
- 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.
- Have an ICD from Boston Scientific under Product Advisory related to magnet performance
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 Criteria
- Have an ICD or PM from Biotronik or Sorin
- Surgical procedures with two or more electrocautery operators.
- 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.
- Have an ICD from Boston Scientific under Product Advisory related to magnet performance
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