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

NCT01599065 | Completed

• 1 other identifier: 01-2011
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sudden Cardiac Death; Arrhythmia; Heart Failure

Keywords

ICD; internal cardioverter defibrillator; electrocautery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Healthcare resources will be less using a magnet protocol compared to an "off-on" protocol. Measures: Cost in dollars

  Up to 90 days

• There will be no difference between adverse events using the magnet protocol compared to using an "off-on" protocol.

  Up to 90 days

• The incidence of EMI will be documented in relation to surgical locations: head/neck, thorax, abdomen/pelvis, upper extremity, lower extremity.

  Up to 90 days

• Number of handoff communication quantified.

  Up to 90 days

Study Arms (2)

Magnet

group treated by disabling ICD during procedure

Other: Magnet or Off-On

Off-On

Group having ICD turned off during the procedure

Other: Magnet or Off-On

Interventions

Magnet or Off-On OTHER

Randomized to ICD suspension using a magnet or turning the ICD off and then back on.

Magnet; Off-On

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have an ICD and are patients at Edward Hospital or Advocate Good Samaritan undergoing surgical, endoscopic and interventional radiologic procedures will be considered for the study. Hospital and cardiology practice staff will identify potential subjects by reviewing surgical, endoscopic and interventional radiologic procedure schedules. When patients with an ICD are identified research staff will be notified. Any scheduled adult patient with a past medical history of an ICD will be considered for participation. If electrocautery is anticipated for the procedure this patient will be screened for the study.

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

Sponsors & Collaborators

• Midwest Heart Foundation: lead
• Abbott Medical Devices: collaborator
• Boston Scientific Corporation: collaborator
• Medtronic: collaborator

Study Sites (3)

Advocate Good Samaritan Hospital

Downers Grove, Illinois, United States

Location

Elmhurst Memorial Hospital

Elmhurst, Illinois, United States

Location

Edward Hospital

Naperville, Illinois, 60540, United States

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Arrhythmias, Cardiac; Heart Failure

Interventions

Magnets

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Janet Gifford, MSN, APN

  Edward Hospital/Midwest Heart Foundation

  PRINCIPAL INVESTIGATOR

• Karen Larimer, PhD, ACNP

  Midwest Heart Specialists-Advocate Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 15, 2012
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 21, 2013

Record last verified: 2012-05

Locations

US (3)