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Interference Between Surgical Magnetic Drapes and Pacemakers

NCT ID: NCT02617355

Last Updated: 2015-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-11-30

Brief Summary

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This study is designed to compare a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to 4 commercially available surgical magnetic drapes.

Detailed Description

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Magnetic fields may potentially interfere with the function of cardiovascular implantable electronic devices. Sterile magnetic drapes used to hold surgical instruments are often placed on the patient's thorax, and they are likely to interfere with the function of these devices.

This study compares the magnetic interference of a new prototype surgical magnetic drape made with bottom-isolated ferrite magnets to the Covidien magnetic drape and 3 other commercially available surgical magnetic drapes.

Conditions

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Electromagnetic Interference

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Prototype vs Covidien magnetic drape

New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs Covidien magnetic drape

Group Type OTHER

Prototype surgical magnetic drape

Intervention Type DEVICE

New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax

Green Covidien Magnetic Drape

Intervention Type DEVICE

Green Covidien Magnetic Drape applied to the patient's thorax

Prototype vs 4 commercial drapes

New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax vs 4 commercially available magnetic drapes:

Green Covidien Magnetic Drape Jac-Cell Medic Reusable Magnetic Pad DeRoyal Magnetic Pad size 10" x 16" DeRoyal Magnetic Pad size 20" x 16"

Group Type OTHER

Prototype surgical magnetic drape

Intervention Type DEVICE

New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax

Green Covidien Magnetic Drape

Intervention Type DEVICE

Green Covidien Magnetic Drape applied to the patient's thorax

Jac-Cell Medic Reusable Magnetic Pad

Intervention Type DEVICE

Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax

DeRoyal Magnetic Pad size 20" x 16"

Intervention Type DEVICE

Magnetic Instrument Pad #25-002, size 20" x 16", DeRoyal Industries Inc applied to the patient's thorax

DeRoyal Magnetic Pad size 10" x 16"

Intervention Type DEVICE

Magnetic Instrument Pad #25-001, size 10" x 16", DeRoyal Industries Inc applied to the patient's thorax

Interventions

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Prototype surgical magnetic drape

New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax

Intervention Type DEVICE

Green Covidien Magnetic Drape

Green Covidien Magnetic Drape applied to the patient's thorax

Intervention Type DEVICE

Jac-Cell Medic Reusable Magnetic Pad

Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax

Intervention Type DEVICE

DeRoyal Magnetic Pad size 20" x 16"

Magnetic Instrument Pad #25-002, size 20" x 16", DeRoyal Industries Inc applied to the patient's thorax

Intervention Type DEVICE

DeRoyal Magnetic Pad size 10" x 16"

Magnetic Instrument Pad #25-001, size 10" x 16", DeRoyal Industries Inc applied to the patient's thorax

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with a pacemaker
* 18 years or older

Exclusion Criteria

* Patients with implantable cardioverter-defibrillator (ICD)
* Patients in whom the magnet rate cardiac rhythm is indistinguishable from their baseline rhythm
* Refusal/Inability to consent
* Language other than French or English
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Valerie Zaphiratos

Clinical associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valerie Zaphiratos, MD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Other Identifiers

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11061

Identifier Type: -

Identifier Source: org_study_id