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

Completed

• Conditions: Arrhythmia; Sudden Cardiac Death; Heart Failure

• Registration Number: NCT01599065
• Lead Sponsor: Midwest Heart Foundation

Brief 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.

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 Timeline

• Study Start: 2011-12
• Status Verified: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Last Update Submitted: 2013-10-18
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of handoff communication quantified.	Up to 90 days	Handoff communications defined as "an exchange of information between staff regarding the ICD subject".
Healthcare resources will be less using a magnet protocol compared to an "off-on" protocol. Measures: Cost in dollars	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.
The incidence of EMI will be documented in relation to surgical locations: head/neck, thorax, abdomen/pelvis, upper extremity, lower extremity.	Up to 90 days	Number of episodes of EMI
There will be no difference between adverse events using the magnet protocol compared to using an "off-on" protocol.	Up to 90 days	1. proportion of subjects with arrhythmias requiring therapy; 2. proportion of subjects with inappropriate ICD therapies; 3. proportion of subjects with pacing inhibition; 4. proportion of subjects with magnet not secured during procedure

Trial Locations

Locations (3)

Advocate Good Samaritan Hospital; 🇺🇸 Downers Grove, Illinois, United States

Elmhurst Memorial Hospital; 🇺🇸 Elmhurst, Illinois, United States

Edward Hospital; 🇺🇸 Naperville, Illinois, United States