Trials / Completed
CompletedNCT02052453
ICD-ON Registry: Periop Management of Cardiac Devices
ICD-ON Registry: Perioperative Management of Pacemakers and Implanted Cardioverter Defibrillators
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 350 (actual)
- Sponsor
- Edward Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2014-02-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2014-02-03
- Last updated
- 2017-07-28
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02052453. Inclusion in this directory is not an endorsement.