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

Heart Failure Clinical Trial

— MAGNET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599065
• Other study ID #: 01-2011
• Status: Completed
• Phase: N/A
• First received: May 10, 2012
• Last updated: October 18, 2013
• Start date: December 2011
• Est. completion date: October 2013

Study information

• Verified date: May 2012
• Source: Midwest Heart Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Death, Sudden, Cardiac
• Heart Failure
• Sudden Cardiac Death

Intervention

Other:
• Magnet or Off-On
Randomized to ICD suspension using a magnet or turning the ICD off and then back on.

Locations

Country	Name	City	State
United States	Advocate Good Samaritan Hospital	Downers Grove	Illinois
United States	Elmhurst Memorial Hospital	Elmhurst	Illinois
United States	Edward Hospital	Naperville	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Midwest Heart Foundation	Boston Scientific Corporation, Medtronic, St. Jude Medical

Country where clinical trial is conducted

United States, 

Outcome

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