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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03016390

Enrollment

100

Registered

2017-01-10

Start date

2016-04-30

Completion date

Unknown

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Electromagnetic Interference in Cardiovascular Implantable Electronic Device

Keywords

Cardiac Implantable Electronic Device, Pacemaker, Automatic Implantable Cardioverter-Defibrillator (AICD), Electromagnetic interference (EMI), Keyless access system, Keyless entry system

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 Only informal studies have been conducted and not be published.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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

1. Age more than 18 years old 2. Able to give informed consent 3. Implanted with functioning pacemakers or AICD more than 3 months 4. Adequate and stable all device parameters 5. Able to operate self triggering event recorders (at least 30 seconds)

Exclusion criteria

1. Patient with single chamber (Atrial) pacemaker (AAI or AAIR) 2. Presence of unstable hemodynamic or conditions 3. Presence of sustained or ongoing arrhythmia, besides atrial fibrillation/atrial flutter in single (ventricle) chamber device or Atrio-ventricular block 4. 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) 5. Lack of noise oversensing detection/trigger and Electrogram (EGM) storage capability 6. Lack of tachyarrhythmia detection and episode storage capability

Design outcomes

Primary

Measure	Time frame
Incidence of any Electromagnetic interference	Immediately after completion of the protocol test

Secondary

Measure	Time frame
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

Outcome results