Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

Completed

• Conditions: Implantable Cardioverter-Defibrillators

• Registration Number: NCT00806377
• Lead Sponsor: Minneapolis Heart Institute Foundation

Brief Summary

The purpose of this study is:

* To document the incidence of electromagnetic oversensing of ICDs during non-thoracic surgery.

* To identify any non-thoracic procedure with a higher incidence of generating electromagnetic oversensing.

* To document the ability of dual chamber ICDs to discriminate electromagnetic oversensing.

Detailed Description

Electrocautery devices used during surgery generate a high electromagnetic field with a frequency that may result in ICD oversensing. Oversensing may in turn result in false detection of a ventricular arrhythmia and for the ICD to discharge. Because of this possibility, patients frequently have their ICDs inactivated prior to the procedure.

Although oversensing appears to be highly unlikely in clinical practice, vast resources are utilized in the process of deactivating and reactivating ICDs for surgeries. In addition, there are reports of deaths from failure to reactivate ICDs following elective surgery.

In this study we intend to document the incidence of oversensing, identify procedures with a higher likelihood of oversensing and evaluate the ability of dual chamber ICDs to discriminate electromagnetic oversensing.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-09
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with Medtronic or Boston Scientific single and dual chamber ICDs

Exclusion Criteria

• Non-thoracic ICD generator placement (abdominal)
• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Electromagnetic oversensing will be reported as a percentage of the total enrolled patients	Assessed at time of procedure

Secondary Outcome Measures

Name	Time	Method
Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing	Assessed at time of procedure
Incidence of dual chamber ICDs discriminating electromagnetic oversensing.	At time of procedure

Trial Locations

Locations (1)

Abbott Northwestern Hospital; 🇺🇸 Minneapolis, Minnesota, United States