Deactivation of Implantable Cardioverter Defibrillator During Non-Thoracic Surgical Procedures - Full Text View

Sponsored by:	Minneapolis Heart Institute Foundation
Information provided by:	Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:	NCT00806377

Purpose

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.

Condition
Implantable Cardioverter-Defibrillators

MedlinePlus related topics: Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Deactivation of Implantable Cardioverter Defibrillator During Non-Thoracic Surgical Procedures

Further study details as provided by Minneapolis Heart Institute Foundation:

Primary Outcome Measures:

Electromagnetic oversensing will be reported as a percentage of the total enrolled patients [ Time Frame: Assessed at time of procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing [ Time Frame: Assessed at time of procedure ] [ Designated as safety issue: Yes ]
Incidence of dual chamber ICDs discriminating electromagnetic oversensing. [ Time Frame: At time of procedure ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients undergoing elective, non-thoracic surgical procedures will be enrolled. Patients will be recruited in roughly equal amounts from the main surgery and the endoscopy center. Patients who are undergoing cataract surgery will also be enrolled.

Criteria

Inclusion Criteria:

Patients with Medtronic or Boston Scientific single and dual chamber ICDs

Exclusion Criteria:

Non-thoracic ICD generator placement (abdominal)
Pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806377

Contacts

Contact: Kari A Williams, BS	612.863.8200	kari.williams@allina.com
Contact: Karen Meyer, RN	612.863.5855	karen.meyer2@allina.com

Locations

United States, Minnesota
Abbott Northwestern Hospital	Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Kari A Williams, BS 612-863-8200 kari.williams@allina.com
Principal Investigator: William T Katsyiannis, MD

Sponsors and Collaborators

Minneapolis Heart Institute Foundation

Investigators

Principal Investigator:

William T Katsyiannis, MD

Minneapolis Heart Institute

More Information

Publications:

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.

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.

Responsible Party:	Minneapolis Heart Institute Foundation ( William Katsiyiannis, MD, Principal Investigator )
Study ID Numbers:	EP001
Study First Received:	December 9, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00806377
Health Authority:	United States: Institutional Review Board

Keywords provided by Minneapolis Heart Institute Foundation:

Electromagnetic field
Oversensing
Non-thoracic surgery

ClinicalTrials.gov processed this record on January 16, 2009