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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
| Boston Scientific Corporation | INDUSTRY |
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnet | group treated by disabling ICD during procedure |
| |
| Off-On | Group having ICD turned off during the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnet or Off-On | Other | Randomized to ICD suspension using a magnet or turning the ICD off and then back on. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Be able to speak and understand English
Be willing to sign consent form
Exclusion criteria
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Janet Gifford, MSN, APN | Edward Hospital/Midwest Heart Foundation | Principal Investigator |
| Karen Larimer, PhD, ACNP | Midwest Heart Specialists-Advocate Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advocate Good Samaritan Hospital | Downers Grove | Illinois | United States | |||
| Elmhurst Memorial Hospital |
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| ID | Term |
|---|---|
| D016757 | Death, Sudden, Cardiac |
| D001145 | Arrhythmias, Cardiac |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D003645 | Death, Sudden |
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| ID | Term |
|---|---|
| D059346 | Magnets |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| 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. | Number of episodes of EMI | Up to 90 days |
| Number of handoff communication quantified. | Handoff communications defined as "an exchange of information between staff regarding the ICD subject". | Up to 90 days |
| Elmhurst |
| Illinois |
| United States |
| Edward Hospital | Naperville | Illinois | 60540 | United States |
| D003643 |
| Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |