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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valerie Zaphiratos, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier:
NCT01009320
First received: November 5, 2009
Last updated: March 5, 2013
Last verified: March 2013
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maisonneuve-Rosemont Hospital:

Primary Outcome Measures:
  • Asynchronous pacing [ Time Frame: Minutes ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Valerie Zaphiratos, Principal investigator, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01009320     History of Changes
Other Study ID Numbers: HMRvzaphi, 09051
Study First Received: November 5, 2009
Last Updated: March 5, 2013
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 18, 2013