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

March 5, 2013 updated by: Valerie Zaphiratos, Maisonneuve-Rosemont Hospital
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Maisonneuve-Rosemont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Out-patient clinic

Description

Inclusion Criteria:

  • Cardiac pacemaker

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Pacemaker with magnets
Patients with pacemakers who will be tested for magnetic interference with a magnetic drape.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Asynchronous pacing
Time Frame: Minutes
Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

November 5, 2009

First Submitted That Met QC Criteria

November 5, 2009

First Posted (Estimate)

November 6, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HMRvzaphi
  • 09051

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiac Pacemaker, Artificial

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe