Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00806377

Acronym

Dinosur

Enrollment

100

Registered

2008-12-10

Start date

2008-12-31

Completion date

2011-10-31

Last updated

2017-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantable Cardioverter-Defibrillators

Keywords

Electromagnetic field, Oversensing, Non-thoracic surgery

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Electromagnetic oversensing will be reported as a percentage of the total enrolled patients	Assessed at time of procedure

Secondary

Measure	Time frame
Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing	Assessed at time of procedure
Incidence of dual chamber ICDs discriminating electromagnetic oversensing.	At time of procedure

Countries

United States

Outcome results