NCT02617355

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

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

October 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 30, 2015

Completed
Last Updated

November 30, 2015

Status Verified

November 1, 2015

Enrollment Period

1 month

First QC Date

November 24, 2015

Last Update Submit

November 27, 2015

Conditions

Electromagnetic Interference

Outcome Measures

Primary Outcomes (1)

  • Percentage of magnetic interference

    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.

    Within 2 minutes after placement of surgical magnetic drape to the patient's chest

Study Arms (2)

Prototype vs Covidien magnetic drape

OTHER

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

Device: Prototype surgical magnetic drapeDevice: Green Covidien Magnetic Drape

Prototype vs 4 commercial drapes

OTHER

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"

Device: Prototype surgical magnetic drapeDevice: Green Covidien Magnetic DrapeDevice: Jac-Cell Medic Reusable Magnetic PadDevice: DeRoyal Magnetic Pad size 20" x 16"Device: DeRoyal Magnetic Pad size 10" x 16"

Interventions

Prototype surgical magnetic drapeDEVICE

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

Prototype vs 4 commercial drapesPrototype vs Covidien magnetic drape
Green Covidien Magnetic DrapeDEVICE

Green Covidien Magnetic Drape applied to the patient's thorax

Prototype vs 4 commercial drapesPrototype vs Covidien magnetic drape
Jac-Cell Medic Reusable Magnetic PadDEVICE

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

Prototype vs 4 commercial drapes
DeRoyal Magnetic Pad size 20" x 16"DEVICE

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

Prototype vs 4 commercial drapes
DeRoyal Magnetic Pad size 10" x 16"DEVICE

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

Prototype vs 4 commercial drapes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a pacemaker
  • years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Valerie Zaphiratos, MD

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate Professor

Study Record Dates

First Submitted

November 24, 2015

First Posted

November 30, 2015

Study Start

October 1, 2011

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

November 30, 2015

Record last verified: 2015-11