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Perioperative Management of Patients With Cardiac Implantable Electronic Devices

Perioperative MAnaGement of patieNts With Cardiac Implantable Electronic Devices: Randomized Controlled Pilot Trial (MAGNET Trial)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02025738
Acronym
MAGNET
Enrollment
150
Registered
2014-01-01
Start date
2014-01-31
Completion date
Unknown
Last updated
2015-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC

Brief 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)

Interventions

DEVICEMAGNET APPLICATION
DEVICEREPROGRAMING
DEVICENO ACTION

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frame
Any inappropriate sensing of EMI caused by electrocautery.DURING SURGERY/PROCEDURE

Secondary

MeasureTime frame
Any significant change in CIEDS parametersWITHIN 1 DAY OF SURGERY/PROCEDURE

Countries

Israel

Contacts

Primary ContactMAHMOUD SULEIMAN, MD
M_SULEIMAN@RAMBAM.HEALTH.GOV.IL972502061385

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026