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

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ClinicalTrials.gov Identifier: NCT03016390
Recruitment Status : Unknown
Verified January 2017 by Narawudt Prasertwitayakij, Chiang Mai University.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : January 10, 2017
Sponsor:
Collaborator:
Thailand Research Fund
Information provided by (Responsible Party):
Narawudt Prasertwitayakij, Chiang Mai University

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 Only informal studies have been conducted and not be published.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

Condition or disease
Electromagnetic Interference in Cardiovascular Implantable Electronic Device

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Study Start Date : April 2016
Estimated Primary Completion Date : April 2017



Primary Outcome Measures :
  1. Incidence of any Electromagnetic interference [ Time Frame: Immediately after completion of the protocol test ]

Secondary Outcome Measures :
  1. Incidence of pacing inhibition in ventricular channel [ Time Frame: Immediately after completion of the protocol test ]
  2. Incidence of noise reversion [ Time Frame: Immediately after completion of the protocol test ]
  3. Incidence of ventricular tachycardia/fibrillation detection [ Time Frame: Immediately after completion of the protocol test ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016390


Sponsors and Collaborators
Chiang Mai University
Thailand Research Fund
Investigators
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Study Chair: Arintaya Phrommintikul, MD Faculty of Medicine, Chiang Mai University
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Responsible Party: Narawudt Prasertwitayakij, lecturer, Chiang Mai University
ClinicalTrials.gov Identifier: NCT03016390    
Other Study ID Numbers: MED-2559-03815
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 10, 2017
Last Verified: January 2017
Keywords provided by Narawudt Prasertwitayakij, Chiang Mai University:
Cardiac Implantable Electronic Device
Pacemaker
Automatic Implantable Cardioverter-Defibrillator (AICD)
Electromagnetic interference (EMI)
Keyless access system
Keyless entry system