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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier:
NCT00806377
First received: December 9, 2008
Last updated: May 9, 2013
Last verified: May 2013
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Deactivation of Implantable Cardioverter Defibrillator During Non-thoracic Surgical Procedures

Resource links provided by NLM:


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 ]

Enrollment: 100
Study Start Date: December 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (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.

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

Locations
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Sponsors and Collaborators
Minneapolis Heart Institute Foundation
Investigators
Principal Investigator: William T Katsyiannis, MD Minneapolis Heart Institute
  More Information

Publications:
Responsible Party: Minneapolis Heart Institute Foundation
ClinicalTrials.gov Identifier: NCT00806377     History of Changes
Other Study ID Numbers: EP001
Study First Received: December 9, 2008
Last Updated: May 9, 2013
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 April 16, 2014