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

NCT03016390 | Unknown

• 1 other identifier: MED-2559-03815
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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 Only informal studies have been conducted and not be published.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

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

Outcome Measures

Primary Outcomes (1)

• Incidence of any Electromagnetic interference

  Immediately after completion of the protocol test

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chiang Mai University: lead
• Thailand Research Fund: collaborator

Related Publications (1)

• Prasertwitayakij N, Komolmis T, Gunaparn S, Pisespongsa C, Phrommintikul A, Wongcharoen W, Nantsupawat T. Electromagnetic interference from automobile passive keyless entry in cardiovascular implantable electronic devices. Expert Rev Med Devices. 2023 Jul-Dec;20(11):973-977. doi: 10.1080/17434440.2023.2255126. Epub 2023 Sep 5.

  PMID: 37668539 DERIVED

Study Officials

• Arintaya Phrommintikul, MD

  Faculty of Medicine, Chiang Mai University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 10, 2017
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Last Updated: January 10, 2017

Record last verified: 2017-01