Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03016390
Recruitment Status : Unknown
Verified January 2017 by Narawudt Prasertwitayakij, Chiang Mai University. Recruitment status was: Active, not recruiting
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 Only informal studies have been conducted and not be published.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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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)
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)
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