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

This study has been completed.
Sponsor:
Collaborators:
St. Jude Medical
Boston Scientific Corporation
Medtronic
Information provided by (Responsible Party):
Karen Larimer, PhD, Midwest Heart Foundation
ClinicalTrials.gov Identifier:
NCT01599065
First received: May 10, 2012
Last updated: October 18, 2013
Last verified: May 2012
  Purpose

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.


Condition Intervention
Sudden Cardiac Death
Arrhythmia
Heart Failure
Other: Magnet or Off-On

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of a MAGNET Protocol Versus "off-on" Protocol for Patients With Implantable Cardioverter Defibrillators Undergoing Procedures Requiring Electrocautery

Resource links provided by NLM:


Further study details as provided by Midwest Heart Foundation:

Primary Outcome Measures:
  • 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. [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Healthcare resources will be less using a magnet protocol compared to an "off-on" protocol. Measures: Cost in dollars [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    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.

  • There will be no difference between adverse events using the magnet protocol compared to using an "off-on" protocol. [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]
    1. proportion of subjects with arrhythmias requiring therapy
    2. proportion of subjects with inappropriate ICD therapies
    3. proportion of subjects with pacing inhibition
    4. proportion of subjects with magnet not secured during procedure

  • The incidence of EMI will be documented in relation to surgical locations: head/neck, thorax, abdomen/pelvis, upper extremity, lower extremity. [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    Number of episodes of EMI

  • Number of handoff communication quantified. [ Time Frame: Up to 90 days ] [ Designated as safety issue: No ]
    Handoff communications defined as "an exchange of information between staff regarding the ICD subject".


Enrollment: 80
Study Start Date: December 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Magnet
group treated by disabling ICD during procedure
Other: Magnet or Off-On
Randomized to ICD suspension using a magnet or turning the ICD off and then back on.
Off-On
Group having ICD turned off during the procedure
Other: Magnet or Off-On
Randomized to ICD suspension using a magnet or turning the ICD off and then back on.

Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01599065

Locations
United States, Illinois
Advocate Good Samaritan Hospital
Downers Grove, Illinois, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States
Edward Hospital
Naperville, Illinois, United States, 60540
Sponsors and Collaborators
Midwest Heart Foundation
St. Jude Medical
Boston Scientific Corporation
Medtronic
Investigators
Principal Investigator: Janet Gifford, MSN, APN Edward Hospital/Midwest Heart Foundation
Principal Investigator: Karen Larimer, PhD, ACNP Midwest Heart Specialists-Advocate Medical Group
  More Information

No publications provided

Responsible Party: Karen Larimer, PhD, Investigator, Midwest Heart Foundation
ClinicalTrials.gov Identifier: NCT01599065     History of Changes
Other Study ID Numbers: 01-2011
Study First Received: May 10, 2012
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Midwest Heart Foundation:
ICD
internal cardioverter defibrillator
electrocautery

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Death, Sudden, Cardiac
Death
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heart Arrest
Death, Sudden

ClinicalTrials.gov processed this record on July 31, 2014