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

NCT ID: NCT01009320

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2009-11-30

Brief Summary

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.

Conditions

Cardiac Pacemaker, Artificial

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Pacemaker with magnets

Patients with pacemakers who will be tested for magnetic interference with a magnetic drape.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Cardiac pacemaker

Exclusion Criteria

• Unstable angina
• Hemodynamic instability
• Subjects whom the cardiologist believes are unsuitable for asynchronous pacing

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Valerie Zaphiratos

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louis-Philippe Fortier, MD, FRCPC

Role: STUDY_DIRECTOR

Maisonneuve-Rosemont hospital, University of Montreal

Valerie Zaphiratos, MD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont hospital, University of Montreal

Locations

Maisonneuve-Rosemont hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

09051

Identifier Type: -

Identifier Source: secondary_id

HMRvzaphi

Identifier Type: -

Identifier Source: org_study_id