Comparison of a MAGNET Protocol Versus "off-on" Protocol for Patients With Implantable Cardioverter Defibrillators
NCT ID: NCT01599065
Last Updated: 2013-10-21
Study Results
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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COMPLETED
80 participants
OBSERVATIONAL
2011-12-31
2013-10-31
Brief Summary
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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.
Detailed Description
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Subjects will be enrolled at the time of their procedure and will remain in the study until their post operative device interrogation. This could take place that same day ("off on" group or registry) or at their next ICD clinic visit or remote transmission (no more than 3 months from the procedure).
The study duration from first enrollment to closure is expected to last approximately 12 months. There will be only two enrolling centers and the target sample size is 150 subjects from various manufacturers. No specific sample size was calculated as this is a pilot study.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Magnet
group treated by disabling ICD during procedure
Magnet or Off-On
Randomized to ICD suspension using a magnet or turning the ICD off and then back on.
Off-On
Group having ICD turned off during the procedure
Magnet or Off-On
Randomized to ICD suspension using a magnet or turning the ICD off and then back on.
Interventions
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Magnet or Off-On
Randomized to ICD suspension using a magnet or turning the ICD off and then back on.
Eligibility Criteria
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Inclusion Criteria
* Have a pectorally implanted ICD
* Be scheduled for surgical procedure with anticipated electrocautery, OR
* Be scheduled for endoscopic procedure with anticipated electrocautery, OR
* Be scheduled for interventional radiology procedure with anticipated electrocautery
* Have a planned procedure with anticipated EC \> 15 cm (6 in) from ICD generator\*
* Have an ICD from the following manufacturer:
* Medtronic, Inc., OR
* Boston Scientific (formerly Guidant/CPI), OR
* St. Jude Medical
* Be able to speak and understand English
* Be willing to sign consent form
* While subjects having procedures \< 15 cm (6 in) from generator will be excluded from the main study they will qualify to be placed in the registry.
Exclusion Criteria
* Be scheduled for a surgical, endoscopic or radiologic procedure where only bipolar electrocautery is planned (ophthalmologic procedures)
* Have an ICD from Boston Scientific under Product Advisory related to magnet performance.
* Have an ICD from the manufacturer ELA or Biotroniks
19 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Boston Scientific Corporation
INDUSTRY
Medtronic
INDUSTRY
Midwest Heart Foundation
OTHER
Responsible Party
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Karen Larimer, PhD
Investigator
Principal Investigators
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Janet Gifford, MSN, APN
Role: PRINCIPAL_INVESTIGATOR
Edward Hospital/Midwest Heart Foundation
Karen Larimer, PhD, ACNP
Role: PRINCIPAL_INVESTIGATOR
Midwest Heart Specialists-Advocate Medical Group
Locations
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Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States
Edward Hospital
Naperville, Illinois, United States
Countries
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Other Identifiers
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01-2011
Identifier Type: -
Identifier Source: org_study_id