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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Brief Summary

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 Only informal studies have been conducted and not be published.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

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Detailed Description

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Conditions

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Electromagnetic Interference in Cardiovascular Implantable Electronic Device

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No