ICD-ON Registry: Periop Management of Cardiac Devices

Sponsor

Edward Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02052453

Collaborator

Medtronic (Industry), Abbott Medical Devices (Industry), Boston Scientific Corporation (Industry)

350

Enrollment

Locations

21.9

Duration (Months)

116.7

Patients Per Site

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Oversensing Cardiac Pacemaker ICD Surgery

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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

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

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.

Other Outcome Measures

Incidence of device reset. [up to 90 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advocate Good Samaritan Hospital	Downers Grove	Illinois	United States	60515
2	Elmhurst Hospital	Elmhurst	Illinois	United States	60126
3	Edward Hospital	Naperville	Illinois	United States	60174