Interference Between Surgical Magnetic Drapes and Pacemakers

Interference Between Surgical Magnetic Drapes and Pacemakers: An Observational Study Comparing Commercially Available Devices and a New Magnetically Isolated Drape

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02617355

Enrollment

Registered

2015-11-30

Start date

2011-10-31

Completion date

2011-11-30

Last updated

2015-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electromagnetic Interference

Brief summary

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

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.

Interventions

DEVICEPrototype surgical magnetic drape

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

DEVICEGreen Covidien Magnetic Drape

Green Covidien Magnetic Drape applied to the patient's thorax

DEVICEJac-Cell Medic Reusable Magnetic Pad

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

DEVICEDeRoyal Magnetic Pad size 20 x 16

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

DEVICEDeRoyal Magnetic Pad size 10 x 16

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of magnetic interference	Within 2 minutes after placement of surgical magnetic drape to the patient's chest	Percentage of patients experiencing magnetic interference with the application of each surgical magnetic drape. Magnetic interference defined as a cardiac rhythm change to asynchronous and identical to that produced by a round magnet rhythm over the pacemaker.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026