ICD-ON Registry: Periop Management of Cardiac Devices

NCT02052453 | Completed

• 1 other identifier: ICDON2013
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 3

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.

Conditions

Oversensing Cardiac Pacemaker; ICD; Surgery

Keywords

Pacemaker; ICD; Surgery; Electrocautery; Electromagnetic interference

Outcome Measures

Primary Outcomes (1)

• Incidence of EMI.

  Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.

  up to 90 days

Secondary Outcomes (1)

• Incidence of pacing inhibition in pacemaker dependent patients with procedures > 6 inches from device.

  up to 90 days

Other Outcomes (1)

• Incidence of device reset.

  up to 90 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have a PM or ICD undergoing procedures with anticipated electrocautery.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Edward Hospital: lead
• Medtronic: collaborator
• Abbott Medical Devices: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (3)

Advocate Good Samaritan Hospital

Downers Grove, Illinois, 60515, United States

Location

Elmhurst Hospital

Elmhurst, Illinois, 60126, United States

Location

Edward Hospital

Naperville, Illinois, 60174, United States

Location

Related 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. No abstract available.

  PMID: 21722856 BACKGROUND

• 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.

  PMID: 24802626 BACKGROUND

Study Officials

• Janet Gifford, MSN, NP

  Edward Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse Practitioner, Cardiology

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 3, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 28, 2017

Record last verified: 2016-07

Locations

US (3)