Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

NCT ID: NCT00806377

Last Updated: 2017-05-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-10-31

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.

Conditions

Implantable Cardioverter-Defibrillators

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minneapolis Heart Institute Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William T Katsyiannis, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Heart Institute

Locations

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Countries

United States

References

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. doi: 10.1111/j.1540-8159.2004.00430.x.

Reference Type: BACKGROUND

PMID: 15009852 (View on PubMed)

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. doi: 10.1016/j.hrthm.2004.05.006.

Reference Type: BACKGROUND

PMID: 15851191 (View on PubMed)

Other Identifiers

EP001

Identifier Type: -

Identifier Source: org_study_id