Clinical trial NCT03016390: Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
Collaborators: name: Thailand Research Fund
First posted: 2017-01-10
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients participated at our Cardiac Rhythm Device Management (CRDM) clinic at Maharaj Nakorn Chiang Mai hospital, Faculty of medicine, Chiang Mai University will be invited. And at least 100 consecutive patients to be equally enrolled in both pacemakers(including single chamber, dual chamber and Cardiac Resynchronization Therapy pacemaker-CRTP) and Automatic Implantable Cardioverter-Defibrillator (AICD) (including single chamber, dual chamber and Bi-ventricular AICD or CRTD)

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 Only informal studies have been conducted and not be published.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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of any Electromagnetic interference
timeFrame: Immediately after completion of the protocol test
Secondary outcomes:
measure: Incidence of pacing inhibition in ventricular channel
timeFrame: Immediately after completion of the protocol test
measure: Incidence of noise reversion
timeFrame: Immediately after completion of the protocol test
measure: Incidence of ventricular tachycardia/fibrillation detection
timeFrame: Immediately after completion of the protocol test
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University
name: Arintaya Phrommintikul, MD
role: STUDY_CHAIR
References: