Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures (Dinosur)

May 30, 2017 updated by: Minneapolis Heart Institute Foundation

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 Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective, non-thoracic surgical procedures will be enrolled.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Heart Institute Foundation

Investigators

  • Principal Investigator: William T Katsyiannis, MD, Minneapolis Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

December 9, 2008

First Submitted That Met QC Criteria

December 9, 2008

First Posted (Estimate)

December 10, 2008

Study Record Updates

Last Update Posted (Actual)

May 31, 2017

Last Update Submitted That Met QC Criteria

May 30, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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