MAGNET: Perioperative Management of Patients With Cardiac Implantable Electronic Devices

Sponsor

Rambam Health Care Campus (Other)

Overall Status

Unknown status

CT.gov ID

NCT02025738

Collaborator

(none)

150

Enrollment

Location

Arms

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC	Device: MAGNET APPLICATION Device: REPROGRAMING Device: NO ACTION	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Any inappropriate sensing of EMI caused by electrocautery. [DURING SURGERY/PROCEDURE]

Secondary Outcome Measures

Any significant change in CIEDS parameters [WITHIN 1 DAY OF SURGERY/PROCEDURE]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rambam Medical Center	Haifa		Israel	31096

Sponsors and Collaborators

Rambam Health Care Campus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Crossley GH, Poole JE, Rozner MA, Asirvatham SJ, Cheng A, Chung MK, Ferguson TB Jr, Gallagher JD, Gold MR, Hoyt RH, Irefin S, Kusumoto FM, Moorman LP, Thompson A. The Heart Rhythm Society (HRS)/American Society of Anesthesiologists (ASA) Expert Consensus Statement on the perioperative management of patients with implantable defibrillators, pacemakers and arrhythmia monitors: facilities and patient management this document was developed as a joint project with the American Society of Anesthesiologists (ASA), and in collaboration with the American Heart Association (AHA), and the Society of Thoracic Surgeons (STS). Heart Rhythm. 2011 Jul;8(7):1114-54. doi: 10.1016/j.hrthm.2010.12.023. Review.

Responsible Party:

Mahmoud Suleiman MD, MD, Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT02025738

Other Study ID Numbers:

MAGNET2014

First Posted:

Jan 1, 2014

Last Update Posted:

May 6, 2015

Last Verified:

May 1, 2015

Study Results

No Results Posted as of May 6, 2015