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

Rambam Health Care Campus

Status: Unknown

Conditions: CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC

Treatments: Device: REPROGRAMING; Device: NO ACTION; Device: MAGNET APPLICATION

Study type: Interventional

Funder types: Other

Identifiers

NCT02025738

MAGNET2014

Details and patient eligibility

About

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)

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 3 patient groups

MAGNET

Active Comparator group

Description:

magnet application over cardiac device

Treatment:

Device: MAGNET APPLICATION

REPROGRAMING

Active Comparator group

Description:

reprograming of cardiac device by trained technician/electrophysiologist

Treatment:

Device: REPROGRAMING

NO ACTION

Active Comparator group

Description:

no action is performed if patient meets inclusion criteria

Treatment:

Device: NO ACTION