NCT01009320

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2009

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

November 5, 2009

Last Update Submit

March 5, 2013

Conditions

Cardiac Pacemaker, Artificial

Keywords

PacemakerMagnetsDrapeFerriteMagnetic fieldPacemaker interference

Outcome Measures

Primary Outcomes (1)

  • Asynchronous pacing

    Minutes

Study Arms (1)

Pacemaker with magnets

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Out-patient clinic

You may qualify if:

  • Cardiac pacemaker

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve-Rosemont hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Study Officials

  • Louis-Philippe Fortier, MD, FRCPC

    Maisonneuve-Rosemont hospital, University of Montreal

    STUDY DIRECTOR

  • Valerie Zaphiratos, MD

    Maisonneuve-Rosemont hospital, University of Montreal

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 6, 2009

Study Start

September 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

CA(1)