CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETICMAGNETNCT02025738
Perioperative Management of Patients With Cardiac Implantable Electronic Devices
A study testing MAGNET APPLICATION, REPROGRAMING and NO ACTION in people with CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC
- What is being tested?
- MAGNET APPLICATION, REPROGRAMING and NO ACTION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2014to Dec 2015
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects with cardiac implanted electronic device (CIED) who are candidates of non-cardio-thoracic surgery or endoscopy and anticipated use of electrocautery
Who cannot join
- Recent CIED implantation (less than 6 weeks)
- Subjects with ICD who are pacemaker dependent
- Cardio - thoracic surgery
- Surgery over the CIED site
- Surgery site that preclude use of magnet in efficient way
- Subjects with Implanted unipolar leads
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative MAnaGement of patieNts With Cardiac Implantable Electronic Devices: Randomized Controlled Pilot Trial (MAGNET Trial)
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these patients. Depending on the device type and patient's dependency, these guidelines recommend the intraoperative magnet use, reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable method) has become the standard approach in many centers, while CIED reprograming by trained personnel is required in most centers. Therefore, our objective is to compare in a prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS reprogramming vs. no intervention (in the appropriate subjects)
- Being tested
- MAGNET APPLICATION, REPROGRAMING, NO ACTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAGNET APPLICATIONDevice
REPROGRAMINGDevice
NO ACTIONDevice
| Study group | Role | What they receive |
|---|---|---|
| MAGNET | Active comparator | magnet application over cardiac device Receives: Device: MAGNET APPLICATION |
| REPROGRAMING | Active comparator | reprograming of cardiac device by trained technician/electrophysiologist Receives: Device: REPROGRAMING |
| NO ACTION | Active comparator | no action is performed if patient meets inclusion criteria Receives: Device: NO ACTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any inappropriate sensing of EMI caused by electrocautery.
Measured: DURING SURGERY/PROCEDURE
Secondary outcomes (1)
Any significant change in CIEDS parameters
Measured: WITHIN 1 DAY OF SURGERY/PROCEDURE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETICStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Suleiman MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025738
- Sponsor's protocol ID
- MAGNET2014
- Acronym
- MAGNET
- Status last verified
- May 2015
- First submitted
- 24 Dec 2013
- Last updated
- 6 May 2015
- Results posted
- No
Publications
Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available.
PubMed 21722856
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative MAnaGement of patieNts With Cardiac Implantable Electronic Devices: Randomized Controlled Pilot Trial (MAGNET Trial)
- ClinicalTrials.gov ID
- NCT02025738
- Acronym / sponsor ID
- MAGNET / MAGNET2014
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (estimated)
- First posted
- 1 Jan 2014 (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.
Data on the perioperative management of patients cardiac implantable electronic devices (CIEDs) is limited and published guidelines rely mainly on the experience of the cardiologists and anesthesiologists who manage these patients. Depending on the device type and patient's dependency, these guidelines recommend the intraoperative magnet use, reprogramming of devices or no action. Magnet placement on a CIED (very simple and applicable method) has become the standard approach in many centers, while CIED reprograming by trained personnel is required in most centers. Therefore, our objective is to compare in a prospective randomized clinical trial the safety of intraoperative magnet use vs. CIEDS reprogramming vs. no intervention (in the appropriate subjects)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAGNET | Active comparator | Device: MAGNET APPLICATIONmagnet application over cardiac device |
| REPROGRAMING | Active comparator | Device: REPROGRAMINGreprograming of cardiac device by trained technician/electrophysiologist |
| NO ACTION | Active comparator | Device: NO ACTIONno action is performed if patient meets inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All subjects with cardiac implanted electronic device (CIED) who are candidates of non-cardio-thoracic surgery or endoscopy and anticipated use of electrocautery
Key exclusion criteria (6 listed)
- Recent CIED implantation (less than 6 weeks)
- Subjects with ICD who are pacemaker dependent
- Cardio - thoracic surgery
- Surgery over the CIED site
- Surgery site that preclude use of magnet in efficient way
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 APPLICATION | Device | MAGNET |
| REPROGRAMING | Device | REPROGRAMING |
| NO ACTION | Device | NO ACTION |
Primary outcome
Any inappropriate sensing of EMI caused by electrocautery.
Time frame: DURING SURGERY/PROCEDURE
1 secondary outcome
Any significant change in CIEDS parameters
Time frame: WITHIN 1 DAY OF SURGERY/PROCEDURE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Background: PubMed 21722856Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. No abstract available.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAGNET APPLICATION, REPROGRAMING and NO ACTION in people with CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC, run by Rambam Health Care Campus at 1 site in Israel.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MAHMOUD SULEIMAN, MD (972502061385, M_SULEIMAN@RAMBAM.HEALTH.GOV.IL), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any inappropriate sensing of EMI caused by electrocautery. (time frame: DURING SURGERY/PROCEDURE). 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 NCT02025738, which also lists 1 linked publication.
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 6 May 2015.