Perioperative Management of Patients With Cardiac Implantable Electronic Devices

CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC Clinical Trial

— MAGNET  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02025738
• Other study ID #: MAGNET2014
• Status: Not yet recruiting
• Phase: N/A
• First received: December 24, 2013
• Last updated: May 5, 2015
• Start date: January 2014

Study information

• Verified date: May 2015
• Source: Rambam Health Care Campus
• Contact: MAHMOUD SULEIMAN, MD
• Phone: 972502061385
• Email: M_SULEIMAN[@]RAMBAM.HEALTH.GOV.IL
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC

Intervention

Device:
• MAGNET APPLICATION

• REPROGRAMING

• NO ACTION

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any inappropriate sensing of EMI caused by electrocautery.		DURING SURGERY/PROCEDURE	Yes
Secondary	Any significant change in CIEDS parameters		WITHIN 1 DAY OF SURGERY/PROCEDURE	Yes