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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Arrhythmia; Sudden Cardiac Death
• Intervention / Treatment: Other: Magnet or Off-On

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Downers Grove, Illinois, United States
      • Advocate Good Samaritan Hospital
    • Elmhurst, Illinois, United States
      • Elmhurst Memorial Hospital
    • Naperville, Illinois, United States, 60540
      • Edward Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who have an ICD and are patients at Edward Hospital or Advocate Good Samaritan undergoing surgical, endoscopic and interventional radiologic procedures will be considered for the study. Hospital and cardiology practice staff will identify potential subjects by reviewing surgical, endoscopic and interventional radiologic procedure schedules. When patients with an ICD are identified research staff will be notified. Any scheduled adult patient with a past medical history of an ICD will be considered for participation. If electrocautery is anticipated for the procedure this patient will be screened for the study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Magnet; group treated by disabling ICD during procedure	Other: 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	Other: Magnet or Off-On; Randomized to ICD suspension using a magnet or turning the ICD off and then back on.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	Up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare resources will be less using a magnet protocol compared to an "off-on" protocol. Measures: Cost in dollars	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.	Up to 90 days
There will be no difference between adverse events using the magnet protocol compared to using an "off-on" protocol.	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	Up to 90 days
The incidence of EMI will be documented in relation to surgical locations: head/neck, thorax, abdomen/pelvis, upper extremity, lower extremity.	Number of episodes of EMI	Up to 90 days
Number of handoff communication quantified.	Handoff communications defined as "an exchange of information between staff regarding the ICD subject".	Up to 90 days

Collaborators and Investigators

• Sponsor: Midwest Heart Foundation
• Collaborators: Boston Scientific Corporation; Medtronic; Abbott Medical Devices
• Investigators: Principal Investigator: Janet Gifford, MSN, APN, Edward Hospital/Midwest Heart Foundation; Principal Investigator: Karen Larimer, PhD, ACNP, Midwest Heart Specialists-Advocate Medical Group

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2013

Study Registration Dates

• First Submitted: May 10, 2012
• First Submitted That Met QC Criteria: May 14, 2012
• First Posted (ESTIMATE): May 15, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2013
• Last Update Submitted That Met QC Criteria: October 18, 2013
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: ICD; electrocautery; internal cardioverter defibrillator
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: 01-2011