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

Cardiac Pacemaker, Artificial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01009320
• Other study ID #: HMRvzaphi
• Secondary ID: 09051
• Status: Completed
• Phase: N/A
• First received: November 5, 2009
• Last updated: March 5, 2013
• Start date: September 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2013
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cardiac pacemaker

Exclusion Criteria:

• Unstable angina

• Hemodynamic instability

• Subjects whom the cardiologist believes are unsuitable for asynchronous pacing

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Cardiac Pacemaker, Artificial

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asynchronous pacing		Minutes	No