Clinical trial NCT00806377: Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures
Official title: Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Implantable Cardioverter-Defibrillators
Keywords: Electromagnetic field
Oversensing
Non-thoracic surgery
Lead sponsor: Minneapolis Heart Institute Foundation
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective, non-thoracic surgical procedures will be enrolled.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Electromagnetic oversensing will be reported as a percentage of the total enrolled patients
timeFrame: Assessed at time of procedure
Secondary outcomes:
measure: Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing
timeFrame: Assessed at time of procedure
measure: Incidence of dual chamber ICDs discriminating electromagnetic oversensing.
timeFrame: At time of procedure
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
Study officials:
affiliation: Minneapolis Heart Institute
name: William T Katsyiannis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1016/j.hrthm.2004.05.006.