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

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 Only informal studies have been conducted and not be published.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

Study Overview

• Status: Unknown
• Conditions: Electromagnetic Interference in Cardiovascular Implantable Electronic Device

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of any Electromagnetic interference	Immediately after completion of the protocol test

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Chiang Mai University
• Collaborators: Thailand Research Fund
• Investigators: Study Chair: Arintaya Phrommintikul, MD, Faculty of Medicine, Chiang Mai University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 9, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Estimate): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Pacemaker; Cardiac Implantable Electronic Device; Automatic Implantable Cardioverter-Defibrillator (AICD); Electromagnetic interference (EMI); Keyless access system; Keyless entry system
• Other Study ID Numbers: MED-2559-03815