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

Completed

Conditions studied: Sudden Cardiac Death, Arrhythmia, Heart Failure

In brief

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.

Key facts

Study ID

NCT01599065

Run by

Midwest Heart Foundation

People needed

80

Starts

2011-12-01

Expected to finish

2013-10-01

Last updated by the study team

2013-10-21

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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