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Completed

NCT Number: NCT01599065

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

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.

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Key information

Conditions

Sudden Cardiac Death Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Advocate Good Samaritan Hospital, Downers Grove, Illinois, United States

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About this study

The study design will be a prospective multi-center randomized controlled trial where subjects will be randomized to either a control group (ICD "off-on" group) or to the experimental group (magnet group) within blocks of type of procedure and site.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • 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 electrocautery is not anticipated
  • 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

Treatment and study plan

Magnet or Off-On

Other

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

Primary outcomes

  1. Number of minutes ICD therapy suspended will be less using a magnet protocol compared to number of minutes ICD therapy suspended using an "off-on" protocol.

    Time frame: Up to 90 days

Secondary outcomes

  1. Healthcare resources will be less using a magnet protocol compared to an "off-on" protocol. Measures: Cost in dollars

    Time frame: Up to 90 days

    Cost of skilled personnel (cost is defined as number of minutes skilled personnel engaged in active management or waiting to be engaged in active management [and not otherwise productive] in management of subject) and cost of equipment (ie. transport monitor, defibrillator and pads) or any equipment necessary to man-age the subject that is unique to either magnet protocol or "off-on" protocol.

  2. There will be no difference between adverse events using the magnet protocol compared to using an "off-on" protocol.

    Time frame: Up to 90 days

    • proportion of subjects with arrhythmias requiring therapy
    • proportion of subjects with inappropriate ICD therapies
    • proportion of subjects with pacing inhibition
    • proportion of subjects with magnet not secured during procedure

  3. The incidence of EMI will be documented in relation to surgical locations: head/neck, thorax, abdomen/pelvis, upper extremity, lower extremity.

    Time frame: Up to 90 days

    Number of episodes of EMI

  4. Number of handoff communication quantified.

    Time frame: Up to 90 days

    Handoff communications defined as "an exchange of information between staff regarding the ICD subject".

Sponsors and collaborators

Lead sponsor

Midwest Heart Foundation

Other

Collaborators

  • Abbott Medical Devices
  • Boston Scientific Corporation
  • Medtronic

Registry information

Official study title

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

Acronym: MAGNET

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
May 15, 2012
Registry last updated
Oct 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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