Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients

Chiang Mai University0 sites100 target enrollmentApril 2016

ConditionsElectromagnetic Interference in Cardiovascular Implantable Electronic Device

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Electromagnetic Interference in Cardiovascular Implantable Electronic Device
Sponsor: Chiang Mai University
Enrollment: 100
Primary Endpoint: Incidence of any Electromagnetic interference
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Cardiovascular Implantable Electronic device (CIED) is a evolution therapy and number of patients with it are growing rapidly. Electromagnetic interference causing device malfunction is not uncommon, Radiofrequency Identification system is among its plausible source. Patients with CIEDs are at risk of exposure to this novel product in their daily living especially automobile keyless access system. Only informal studies have been conducted and not be published. Formal and systemic evaluation and tests are crucial.

Registry

clinicaltrials.gov

Start Date

April 2016

End Date

April 2017

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Chiang Mai University

Responsible Party

Principal Investigator

Narawudt Prasertwitayakij

lecturer

Chiang Mai University

Eligibility Criteria

Inclusion Criteria

•Age more than 18 years old
•Able to give informed consent
•Implanted with functioning pacemakers or AICD more than 3 months
•Adequate and stable all device parameters
•Able to operate self triggering event recorders (at least 30 seconds)

Exclusion Criteria

•Patient with single chamber (Atrial) pacemaker (AAI or AAIR)
•Presence of unstable hemodynamic or conditions
•Presence of sustained or ongoing arrhythmia, besides atrial fibrillation/atrial flutter in single (ventricle) chamber device or Atrio-ventricular block
•Documented of over-sensing episodes under regular sensitivity threshold (0.25 mV or more in the atrial channel and 0.75 mV or more in the ventricular channel, for permanent pacemaker device, and manufacture default setting in Automatic Implantable Cardioverter-Defibrillator, AICD)
•Lack of noise oversensing detection/trigger and Electrogram (EGM) storage capability
•Lack of tachyarrhythmia detection and episode storage capability

Outcomes

Primary Outcomes

Incidence of any Electromagnetic interference

Time Frame: Immediately after completion of the protocol test

Secondary Outcomes

Incidence of pacing inhibition in ventricular channel(Immediately after completion of the protocol test)
Incidence of noise reversion(Immediately after completion of the protocol test)
Incidence of ventricular tachycardia/fibrillation detection(Immediately after completion of the protocol test)