Electromagnetic Interference in Cardiovascular Implantable Electronic DeviceNCT03016390
Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients
An observational study of Electromagnetic Interference in Cardiovascular Implantable Electronic Device, run by Chiang Mai University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Electromagnetic Interference in Cardiovascular Implantable Electronic Device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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.
- Keywords
- Cardiac Implantable Electronic Device, Pacemaker, Automatic Implantable Cardioverter-Defibrillator (AICD), Electromagnetic interference (EMI), Keyless access system, Keyless entry system
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of any Electromagnetic interference
Measured: Immediately after completion of the protocol test
Secondary outcomes (3)
Incidence of pacing inhibition in ventricular channel
Measured: Immediately after completion of the protocol test
Incidence of noise reversion
Measured: Immediately after completion of the protocol test
Incidence of ventricular tachycardia/fibrillation detection
Measured: Immediately after completion of the protocol test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startApr 2016
- Primary completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Electromagnetic Interference in Cardiovascular Implantable Electronic DeviceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Collaborators
- Thailand Research Fund
- Responsible party
- Principal investigator, Narawudt Prasertwitayakij, Chiang Mai University
- Investigators
- Arintaya Phrommintikul, MD, Study chair, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016390
- Sponsor's protocol ID
- MED-2559-03815
- Status last verified
- Jan 2017
- First submitted
- 9 Jan 2017
- Last updated
- 10 Jan 2017
- Results posted
- No
Publications
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.
PubMed 37668539
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromagnetic Interference and Automobile Remote Keyless Entry in Cardiovascular Implantable Electronic Device (CIED) Patients
- ClinicalTrials.gov ID
- NCT03016390
- Acronym / sponsor ID
- MED-2559-03815
- Keywords
- Cardiac Implantable Electronic Device, Pacemaker, Automatic Implantable Cardioverter-Defibrillator (AICD), Electromagnetic interference (EMI), Keyless access system, Keyless entry system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Collaborators
- Thailand Research Fund
- Study start
- Apr 2016
- Primary completion
- Apr 2017 (estimated)
- First posted
- 10 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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)
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of any Electromagnetic interference
Time frame: Immediately after completion of the protocol test
3 secondary outcomes
Incidence of pacing inhibition in ventricular channel
Time frame: Immediately after completion of the protocol test
Incidence of noise reversion
Time frame: Immediately after completion of the protocol test
Incidence of ventricular tachycardia/fibrillation detection
Time frame: Immediately after completion of the protocol test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Derived from this study: PubMed 37668539Prasertwitayakij 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arintaya Phrommintikul, MD study chair
Faculty of Medicine, Chiang Mai University
Questions about this trial
What is this clinical trial studying?
An observational study of Electromagnetic Interference in Cardiovascular Implantable Electronic Device, run by Chiang Mai University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of any Electromagnetic interference (time frame: Immediately after completion of the protocol test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03016390, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2017.