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

Midwest Heart Foundation

Status

Completed

Conditions

Arrhythmia

Heart Failure

Sudden Cardiac Death

Treatments

Other: Magnet or Off-On

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01599065

01-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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