Perioperative Management of Patients With Cardiac Implantable Electronic Devices

Not Applicable

• Conditions: CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC
• Interventions: Device: NO ACTION; Device: MAGNET APPLICATION; Device: REPROGRAMING

• Registration Number: NCT02025738
• Lead Sponsor: Rambam Health Care Campus

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-24
• Study First Submitted QC: 2013-12-29
• Study Start: 2014-01
• Study First Posted: 2014-01-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-05
• Last Update Posted: 2015-05-06
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NO ACTION	NO ACTION	no action is performed if patient meets inclusion criteria
MAGNET	MAGNET APPLICATION	magnet application over cardiac device
REPROGRAMING	REPROGRAMING	reprograming of cardiac device by trained technician/electrophysiologist

Primary Outcome Measures

Name	Time	Method
Any inappropriate sensing of EMI caused by electrocautery.	DURING SURGERY/PROCEDURE

Secondary Outcome Measures

Name	Time	Method
Any significant change in CIEDS parameters	WITHIN 1 DAY OF SURGERY/PROCEDURE

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel