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Clinical Trials/NCT02025738
NCT02025738UnknownNot Applicable

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

Rambam Health Care Campus1 site in 1 country150 target enrollmentStarted: January 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Locations
1
Primary Endpoint
Any inappropriate sensing of EMI caused by electrocautery.

Study Overview

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)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

  • •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

Arms & Interventions

MAGNET

Active Comparator

magnet application over cardiac device

Intervention: MAGNET APPLICATION (Device)

REPROGRAMING

Active Comparator

reprograming of cardiac device by trained technician/electrophysiologist

Intervention: REPROGRAMING (Device)

NO ACTION

Active Comparator

no action is performed if patient meets inclusion criteria

Intervention: NO ACTION (Device)

Outcomes

Primary Outcomes

Any inappropriate sensing of EMI caused by electrocautery.

Time Frame: DURING SURGERY/PROCEDURE

Secondary Outcomes

  • Any significant change in CIEDS parameters(WITHIN 1 DAY OF SURGERY/PROCEDURE)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Suleiman MD

MD

Rambam Health Care Campus

Study Sites (1)

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