ICD-ON Registry: Periop Management of Cardiac Devices

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02052453
• Other study ID #: ICDON2013
• Status: Completed
• Phase: N/A
• First received: January 30, 2014
• Last updated: July 26, 2017
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Edward-Elmhurst Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• ICD
• Oversensing Cardiac Pacemaker
• Surgery

Locations

Country	Name	City	State
United States	Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	Elmhurst Hospital	Elmhurst	Illinois
United States	Edward Hospital	Naperville	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Edward Hospital	Boston Scientific Corporation, Medtronic, St. Jude Medical

Country where clinical trial is conducted

United States, 

References & Publications (2)

Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. Review. — View Citation

Gifford J, Larimer K, Thomas C, May P, Stanhope S, Gami A. Randomized controlled trial of perioperative ICD management: magnet application versus reprogramming. Pacing Clin Electrophysiol. 2014 Sep;37(9):1219-24. doi: 10.1111/pace.12417. Epub 2014 May 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of device reset.	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.	up to 90 days
Primary	Incidence of EMI.	Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.	up to 90 days
Secondary	Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.	Percentage of patients with pacing inhibition recorded intraoperative or on postoperative electrograms during time of electrocautery.	up to 90 days