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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms

  • Implantable Cardioverter-Defibrillators

NCT number NCT00806377
Study type Observational
Source Minneapolis Heart Institute Foundation
Contact
Status Completed
Phase N/A
Start date December 2008
Completion date October 2011

See also
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Terminated NCT04600921 - Ertugliflozin to Reduce Arrhythmic Burden in ICD/CRT patientS (ERASe-Trial) - a Phase III Study Phase 3
Completed NCT00822965 - Enhancing Knowledge Implantable Cardioverter-Defibrillators (ICDs) N/A
Completed NCT00989417 - Benefits of Implantable Cardioverter Defibrillator Follow-up Using Remote Monitoring N/A
Completed NCT04206371 - Defibrillation Testing During Implantable Cardioverter Defibrillator (ICD) Replacement N/A