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

Status:	Completed
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	19 - Any
Updated:	10/19/2013
Start Date:	December 2011
End Date:	April 2013
Contact:	Janet Gifford, MSN, APN
Email:	jgifford@edward.org
Phone:	630-527-3530

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.

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.

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

We found this trial at

sites

Edward Hospital

Naperville, Illinois 60566

from

Naperville, IL