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OpenTrials
Completed

NCT Number: NCT00806377

Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

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.

Completed

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Key information

Conditions

Implantable Cardioverter-Defibrillators

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Electromagnetic oversensing will be reported as a percentage of the total enrolled patients

    Time frame: Assessed at time of procedure

Secondary outcomes

  1. Non-thoracic procedures with a higher incidence of generating electromagnetic oversensing

    Time frame: Assessed at time of procedure

  2. Incidence of dual chamber ICDs discriminating electromagnetic oversensing.

    Time frame: At time of procedure

Sponsors and collaborators

Lead sponsor

Minneapolis Heart Institute Foundation

Other

Registry information

Acronym: Dinosur

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 10, 2008
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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