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The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01009320
First Posted: November 6, 2009
Last Update Posted: March 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valerie Zaphiratos, Maisonneuve-Rosemont Hospital
  Purpose
Magnetic fields may interfere with the function of cardiac pacemakers. A magnetic drape to hold surgical instruments is widely used in surgery. The use of this drape on pacemaker patients has not yet been tested. Our objective is to conduct a clinical study to evaluate the potential interference of the surgical magnetic drape on patients with cardiac pacemakers. We are testing the magnetic drape on forty patients in the pacemaker clinic. The totality of the drape is applied over the pacemaker and depending on the result, the drape is either folded in two over the pacemaker or the magnets are applied individually up to the totality of the drape, 70 magnets. Thereafter, the drape is pulled in increments of 3 cm caudally until the interference is ceased. Results are in process as we are presently actively recruiting.

Condition
Cardiac Pacemaker, Artificial

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Potential Interference of Magnets From a Surgical Magnetic Drape With Cardiac Pacemakers

Further study details as provided by Valerie Zaphiratos, Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Asynchronous pacing [ Time Frame: Minutes ]

Enrollment: 50
Study Start Date: September 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pacemaker with magnets
Patients with pacemakers who will be tested for magnetic interference with a magnetic drape.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Out-patient clinic
Criteria

Inclusion Criteria:

  • Cardiac pacemaker

Exclusion Criteria:

  • Unstable angina
  • Hemodynamic instability
  • Subjects whom the cardiologist believes are unsuitable for asynchronous pacing
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009320


Locations
Canada, Quebec
Maisonneuve-Rosemont hospital
Montreal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Investigators
Study Director: Louis-Philippe Fortier, MD, FRCPC Maisonneuve-Rosemont hospital, University of Montreal
Principal Investigator: Valerie Zaphiratos, MD Maisonneuve-Rosemont hospital, University of Montreal
  More Information

Responsible Party: Valerie Zaphiratos, Principal investigator, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01009320     History of Changes
Other Study ID Numbers: HMRvzaphi
09051
First Submitted: November 5, 2009
First Posted: November 6, 2009
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Valerie Zaphiratos, Maisonneuve-Rosemont Hospital:
Pacemaker
Magnets
Drape
Ferrite
Magnetic field
Pacemaker interference