Perioperative Management of Patients With Cardiac Implantable Electronic Devices (MAGNET)

May 5, 2015 updated by: Mahmoud Suleiman MD, Rambam Health Care Campus

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
        • Principal Investigator:
          • MAHMOUD SULEIMAN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Any inappropriate sensing of EMI caused by electrocautery.
Time Frame: DURING SURGERY/PROCEDURE
DURING SURGERY/PROCEDURE

Secondary Outcome Measures

Outcome Measure
Time Frame
Any significant change in CIEDS parameters
Time Frame: WITHIN 1 DAY OF SURGERY/PROCEDURE
WITHIN 1 DAY OF SURGERY/PROCEDURE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

December 24, 2013

First Submitted That Met QC Criteria

December 29, 2013

First Posted (ESTIMATE)

January 1, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2015

Last Update Submitted That Met QC Criteria

May 5, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • MAGNET2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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