Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

Implantable Cardioverter-Defibrillators Clinical Trial

— Dinosur  

Official title:

Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00806377
• Other study ID #: EP001
• Status: Completed
• Phase: N/A
• First received: December 9, 2008
• Last updated: May 30, 2017
• Start date: December 2008
• Est. completion date: October 2011

Study information

• Verified date: May 2017
• Source: Minneapolis Heart Institute Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Non-thoracic ICD generator placement (abdominal)

• Pregnant

Related Conditions & MeSH terms

• Implantable Cardioverter-Defibrillators

Locations

Country	Name	City	State
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

Fiek M, Dorwarth U, Durchlaub I, Janko S, Von Bary C, Steinbeck G, Hoffmann E. Application of radiofrequency energy in surgical and interventional procedures: are there interactions with ICDs? Pacing Clin Electrophysiol. 2004 Mar;27(3):293-8. — View Citation

Hauser RG, Kallinen L. Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database. Heart Rhythm. 2004 Oct;1(4):399-405. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Electromagnetic oversensing will be reported as a percentage of the total enrolled patients		Assessed at time of procedure
Secondary	Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing		Assessed at time of procedure
Secondary	Incidence of dual chamber ICDs discriminating electromagnetic oversensing.		At time of procedure