NCT03016390UnknownNot Applicable
Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Chiang Mai University
- Enrollment
- 100
- Primary Endpoint
- Incidence of any Electromagnetic interference
Study 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 Only informal studies have been conducted and not be published.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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Narawudt Prasertwitayakij
lecturer
Chiang Mai University
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