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Comparison of a MAGNET Protocol Versus "off-on" Protocol for Patients With Implantable Cardioverter Defibrillators

NCT01599065 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2013-10-21

No results posted yet for this study

Summary

The purpose of this study is to compare the two options for management of ICDs (internal cardioverter defibrillators) in patients undergoing procedures with electrocautery: (1) programming ICD therapies "off," or (2) use of a magnet to suspend ICD therapies By comparing these two techniques the investigators hope to demonstrate the efficiency of using an ICD magnet protocol during perioperative management of patients undergoing electrocautery procedures. Secondary purposes are to gain further information on health care resources, incidence of EMI, handoff communications and to document lack of adverse events in either group.

Primary objective will be: ICD therapy "off times" will be less with the use of a magnet protocol compared to an "off-on" protocol. Secondary objectives will be: (1) Healthcare resources (time and costs of skilled personnel) will be less using a magnet protocol compared to an off-on protocol, and (2) there will be no difference between adverse events in the magnet protocol compared to an off-on protocol. The incidence of EMI and number of handoff communications will be documented.

The investigators hypothesis is that the number of minutes with ICD therapies "off" will be significantly less with magnet use. The investigators also expect health care resources to be less with magnet use compared to reprogramming.

Conditions

Interventions

OTHER

Magnet or Off-On

Randomized to ICD suspension using a magnet or turning the ICD off and then back on.

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Medtronic

    collaborator INDUSTRY

  • Midwest Heart Foundation

    lead OTHER

Principal Investigators

  • Janet Gifford, MSN, APN · Edward Hospital/Midwest Heart Foundation

  • Karen Larimer, PhD, ACNP · Midwest Heart Specialists-Advocate Medical Group

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599065 on ClinicalTrials.gov