Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures (Dinosur)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures|
- 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 ]
- 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 ]
|Study Start Date:||December 2008|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00806377
|United States, Minnesota|
|Abbott Northwestern Hospital|
|Minneapolis, Minnesota, United States, 55407|
|Principal Investigator:||William T Katsyiannis, MD||Minneapolis Heart Institute|