Perioperative MAnaGement of patieNts With Cardiac Implantable Electronic Devices: Randomized Controlled Pilot Trial (MAGNET Trial)
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Rambam Health Care Campus
- 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
magnet application over cardiac device
Intervention: MAGNET APPLICATION (Device)
REPROGRAMING
reprograming of cardiac device by trained technician/electrophysiologist
Intervention: REPROGRAMING (Device)
NO ACTION
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
Mahmoud Suleiman MD
MD
Rambam Health Care Campus
