Perioperative Management of Patients With Cardiac Implantable Electronic Devices

NCT ID: NCT02025738

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31

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)

Conditions

CARDIAC PACEMAKERS DEFIBRILLATOR ELECTROMAGNETIC

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MAGNET

magnet application over cardiac device

Group Type: ACTIVE_COMPARATOR

MAGNET APPLICATION

Intervention Type: DEVICE

REPROGRAMING

reprograming of cardiac device by trained technician/electrophysiologist

Group Type: ACTIVE_COMPARATOR

REPROGRAMING

Intervention Type: DEVICE

NO ACTION

no action is performed if patient meets inclusion criteria

Group Type: ACTIVE_COMPARATOR

NO ACTION

Intervention Type: DEVICE

Interventions

MAGNET APPLICATION

Intervention Type: DEVICE

REPROGRAMING

Intervention Type: DEVICE

NO ACTION

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Suleiman MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rambam Medical Center

Haifa, , Israel

Countries

Israel

Central Contacts

MAHMOUD SULEIMAN, MD

Role: CONTACT

M_SULEIMAN@RAMBAM.HEALTH.GOV.IL

972502061385

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 21722856 (View on PubMed)

Other Identifiers

MAGNET2014

Identifier Type: -

Identifier Source: org_study_id