ICD-ON Registry: Periop Management of Cardiac Devices

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02052453

Enrollment

350

Registered

2014-02-03

Start date

2014-02-28

Completion date

2015-12-31

Last updated

2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ICD, Oversensing Cardiac Pacemaker, Surgery

Keywords

Pacemaker, ICD, Surgery, Electrocautery, Electromagnetic interference

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Incidence of EMI.	up to 90 days	Percentage of patients with EMI, defined as oversensing on atrial or ventricular electrograms during electrocautery.

Secondary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results