Mobile ECG monitoring for detecting heart rhythm issues in children
Effectiveness of Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children With Symptoms: A Randomized Clinical Trial
This study is testing whether using a mobile ECG can help doctors find heart rhythm problems in children aged 5-18 who have symptoms like palpitations or fainting.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Centro Medico Teknon Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05140343 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of mobile electrocardiogram monitoring in detecting arrhythmic events in children who experience symptoms like palpitations or syncope. The study will compare this mobile approach with traditional clinical follow-up and 24-hour Holter ECG monitoring to assess its acceptability and ability to identify significant arrhythmias. Given the challenges in diagnosing arrhythmias in children, this innovative method could provide a more accessible and efficient diagnostic tool. The study will include children aged 5-18 years, with or without structural heart disease, who exhibit symptoms suggestive of rhythm disorders.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-18 years with symptoms of palpitations, syncope, or dizziness, regardless of whether they have a structural heart disease diagnosis.
Not a fit: Patients who are already diagnosed with arrhythmic events or those with medical or social factors that hinder participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnoses of arrhythmias in children, potentially preventing serious complications.
How similar studies have performed: While mobile ECG monitoring is a growing field, this specific approach in pediatric populations is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 5-18 years old with or without the diagnosis of structural heart disease and symptoms suggestive of rhythm disorders as follows: palpitations and/or syncope and/or dizziness. * 24-hours Holter without diagnosis of arrhythmia. * Having an smart phone, smart watch, or tablet (the patient itself or a family member who lives together with the patient) compatible with KARDIA mobile ECG monitoring. * Signed informed consent. In cases under the age of \<18 y.o informed consent should be signed by parents or guardians. Exclusion Criteria: * Concomitant investigation treatments. * Being already diagnosed for arrhythmic events. * Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. * Patient's refusal to participate in the study.
Where this trial is running
Barcelona
- Centro Medico Teknon — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Antonio Berruezo, MD, PhD — Centro Médico Teknon
- Study coordinator: Antonio Berruezo, MD, PhD
- Email: antonio.berruezo@quironsalud.es
- Phone: (+34)932906251
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.