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Status unknownNCT02025738MAGNETUpdated May 6, 2015

Perioperative Management of Patients With Cardiac Implantable Electronic Devices

An interventional study of MAGNET APPLICATION and REPROGRAMING in CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC, sponsored by Rambam Health Care Campus. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-06.

Sponsored by Rambam Health Care Campus · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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)

02

Conditions studied

  • CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC
03

In context

Lead sponsor

Rambam Health Care Campus is the lead sponsor of 456 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • All subjects with cardiac implanted electronic device (CIED) who are candidates of non-cardio-thoracic surgery or endoscopy and anticipated use of electrocautery

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    MAGNET

    magnet application over cardiac device

    Device: MAGNET APPLICATION

  • Active comparator
    REPROGRAMING

    reprograming of cardiac device by trained technician/electrophysiologist

    Device: REPROGRAMING

  • Active comparator
    NO ACTION

    no action is performed if patient meets inclusion criteria

    Device: NO ACTION

Interventions

  • DeviceMAGNET APPLICATION
  • DeviceREPROGRAMING
  • DeviceNO ACTION
06

What researchers measure

Primary outcomes

  1. Any inappropriate sensing of EMI caused by electrocautery.

    Time frame: DURING SURGERY/PROCEDURE

Secondary outcomes

  1. Any significant change in CIEDS parameters

    Time frame: WITHIN 1 DAY OF SURGERY/PROCEDURE

07

Study locations

1 site
  • Rambam Medical Center
    Haifa, 31096, Israel
    • MAHMOUD SULEIMAN, MD · Principal investigator
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02025738
Lead sponsor
Rambam Health Care Campus
Responsible party
Mahmoud Suleiman MD (MD, Rambam Health Care Campus) — Principal investigator
First posted
Jan 1, 2014
Start date
Jan 2014
Primary completion
Dec 2015 (estimated)
Last update
May 6, 2015

Study contacts

MAHMOUD SULEIMAN, MD
Contact
M_SULEIMAN@RAMBAM.HEALTH.GOV.IL
972502061385
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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