Sudden Cardiac DeathMAGNETNCT01599065

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

An observational study of Sudden Cardiac Death and Arrhythmia, run by Midwest Heart Foundation at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 years and older
Conditions the study is for: Sudden Cardiac Death, Arrhythmia, Heart Failure
What is being tested?: Magnet or Off-On
How many people: 80 participants
Where: 3 sitesUnited States
Study dates: Dec 2011to Oct 2013
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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*

Show all 13Show fewer

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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Advocate Good Samaritan Hospital
Downers Grove, Illinois
Elmhurst Memorial Hospital
Elmhurst, Illinois
Edward Hospital
Naperville, Illinois, 60540

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Sudden Cardiac Death, Arrhythmia, Heart Failure
Being tested: Magnet or Off-On
Keywords: ICD, internal cardioverter defibrillator, electrocautery
Medical subject headings: Death, Sudden, Cardiac, Arrhythmias, Cardiac, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01599065
Study group	Role	What they receive
Magnet		group treated by disabling ICD during procedure Receives: Other: Magnet or Off-On
Off-On		Group having ICD turned off during the procedure Receives: Other: Magnet or Off-On

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: Up to 90 days
There will be no difference between adverse events using the magnet protocol compared to using an "off-on" protocol.
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
Measured: 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
Measured: Up to 90 days
Number of handoff communication quantified.
Handoff communications defined as "an exchange of information between staff regarding the ICD subject".
Measured: Up to 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Oct 2013

First posted15 May 2012 (estimated)
Study startDec 2011
Primary completionOct 2013
Study completionOct 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01599065
Sponsor's protocol ID: 01-2011
Acronym: MAGNET
Status last verified: May 2012
First submitted: 10 May 2012
Last updated: 21 Oct 2013
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of a MAGNET Protocol Versus "off-on" Protocol for Patients With Implantable Cardioverter Defibrillators Undergoing Procedures Requiring Electrocautery
ClinicalTrials.gov ID: NCT01599065
Acronym / sponsor ID: MAGNET / 01-2011
Conditions: Sudden Cardiac Death, Arrhythmia, Heart Failure
Keywords: ICD, internal cardioverter defibrillator, electrocautery
Study type: Observational
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Midwest Heart FoundationUniversity, hospital or other
Collaborators: Abbott Medical Devices, Boston Scientific Corporation, Medtronic
Study start: Dec 2011
Primary completion: Oct 2013 (actual)
Study completion: Oct 2013 (actual)
First posted: 15 May 2012 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Magnet	–	Other: Magnet or Off-Ongroup treated by disabling ICD during procedure
Off-On	–	Other: Magnet or Off-OnGroup having ICD turned off during the procedure

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (13 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Magnet or Off-OnRandomized to ICD suspension using a magnet or turning the ICD off and then back on.	Other	Magnet, Off-On

Primary outcome

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

4 secondary outcomes

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
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
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
Number of handoff communication quantified.
Time frame: Up to 90 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet Gifford, MSN, APN principal investigator

Edward Hospital/Midwest Heart Foundation

Karen Larimer, PhD, ACNP principal investigator

Midwest Heart Specialists-Advocate Medical Group

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sudden Cardiac Death and Arrhythmia, run by Midwest Heart Foundation at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01599065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2013.