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

• 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 ] [ Designated as safety issue: No ]
  

• 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 ] [ Designated as safety issue: No ]
  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.
  
  
• 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 ] [ Designated as safety issue: Yes ]
  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
  
  
• 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 ] [ Designated as safety issue: No ]
  Number of episodes of EMI
  
  
• Number of handoff communication quantified. [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
  Handoff communications defined as "an exchange of information between staff regarding the ICD subject".
  
  

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.