Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children

NCT05140343 | Unknown DMC

• 1 other identifier: SMART-CHILD
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this project is to evaluate the capability of a specific mobile electrocardiogram monitoring of detecting arrhythmic events in children with history of palpitation and or syncope. We will compare this approach with the standard approach of clinical follow-up plus 24-hour Holter ECG monitoring in terms of acceptability and ability to identify significant arrhythmias.

Conditions

Arrhythmias, Cardiac; Children, Only; Congenital Heart Disease; Sudden Cardiac Death; Diagnoses Disease

Keywords

grown ups with congenital heart (GUCH) disease; pediatric cardiology; diagnosis of arrhythmia; new diagnostic tools; early diagnosis; prevention

Outcome Measures

Primary Outcomes (1)

• Time to a documented new arrhythmia.

  Time to a documented new arrhythmia counting time from the inclusion date.

  12 months

Secondary Outcomes (2)

• Incidence of medical request

  12 months

• Hospitalization during study time.

  12 months

Study Arms (2)

Mobile ECG Monitoring

EXPERIMENTAL

Standard care with clinical follow-up plus Mobile ECG Monitoring.

Diagnostic Test: KARDIA Mobile ECG Monitoring (KMCM)

24-hour Holter monitoring

NO INTERVENTION

Standard care with clinical follow-up plus repeating 24-hours Holter ECG (month 1, 6, 12)

Interventions

KARDIA Mobile ECG Monitoring (KMCM) DIAGNOSTIC_TEST

The KMCM will be introduced to the patient of the KMCM arm in the outpatient clinic. The activation and configuration will be done together with the physician in the outpatient clinic (installation of the ECG app, enabling heart rate rhythm notification). Patients are requested to acquired ECGs twice weekly plus additional ECGs if symptomatic. In case of symptoms the patient is asked to generate an ECG and communicate the event timely to the investigator and to the treating physician by sending a report through the ECG app. An e-mail account created for the study will be checked at least once a day. The arrhythmia diagnosis will be performed by the clinician based on the ECG information, independently of the arrhythmia classification automatically performed by the device. In case of stronger symptoms of any kind at any time the patient is asked to request medical help regardless of the KMCM notifications. Change of management will be collected.

Mobile ECG Monitoring

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Medico Teknon: lead

Study Sites (1)

Centro Medico Teknon

Barcelona, 08022, Spain

RECRUITING

Related Publications (19)

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• Buddhe S, Singh H, Du W, Karpawich PP. Radiofrequency and cryoablation therapies for supraventricular arrhythmias in the young: five-year review of efficacies. Pacing Clin Electrophysiol. 2012 Jun;35(6):711-7. doi: 10.1111/j.1540-8159.2012.03372.x. Epub 2012 Mar 27.

  PMID: 22452328 BACKGROUND

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  PMID: 9472212 BACKGROUND

• Sedaghat-Yazdi F, Koenig PR. The teenager with palpitations. Pediatr Clin North Am. 2014 Feb;61(1):63-79. doi: 10.1016/j.pcl.2013.09.010. Epub 2013 Oct 12.

  PMID: 24267458 BACKGROUND

• Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.

  PMID: 29562304 BACKGROUND

• MacCormick JM, McAlister H, Crawford J, French JK, Crozier I, Shelling AN, Eddy CA, Rees MI, Skinner JR. Misdiagnosis of long QT syndrome as epilepsy at first presentation. Ann Emerg Med. 2009 Jul;54(1):26-32. doi: 10.1016/j.annemergmed.2009.01.031. Epub 2009 Mar 12.

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• Johnson ER, Etheridge SP, Minich LL, Bardsley T, Heywood M, Menon SC. Practice variation and resource use in the evaluation of pediatric vasovagal syncope: are pediatric cardiologists over-testing? Pediatr Cardiol. 2014 Jun;35(5):753-8. doi: 10.1007/s00246-013-0848-4. Epub 2013 Dec 17.

  PMID: 24343729 BACKGROUND

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  PMID: 23246387 BACKGROUND

• Nakano Y, Wataru S. Syncope in patients with inherited arrhythmias. J Arrhythm. 2017 Dec;33(6):572-578. doi: 10.1016/j.joa.2017.07.007. Epub 2017 Oct 6.

  PMID: 29255503 BACKGROUND

• Longmuir PE, Sampson M, Ham J, Weekes M, Patel BJ, Gow RM. The mental health of adolescents and pre-adolescents living with inherited arrhythmia syndromes: a systematic review of the literature. Cardiol Young. 2018 May;28(5):621-631. doi: 10.1017/S104795111700289X. Epub 2018 Jan 18.

  PMID: 29345602 BACKGROUND

• von Alvensleben JC. Syncope and Palpitations: A Review. Pediatr Clin North Am. 2020 Oct;67(5):801-810. doi: 10.1016/j.pcl.2020.05.004. Epub 2020 Aug 11.

  PMID: 32888682 BACKGROUND

• Sliwa K, Azibani F, Johnson MR, Viljoen C, Baard J, Osman A, Briton O, Ntsekhe M, Chin A. Effectiveness of Implanted Cardiac Rhythm Recorders With Electrocardiographic Monitoring for Detecting Arrhythmias in Pregnant Women With Symptomatic Arrhythmia and/or Structural Heart Disease: A Randomized Clinical Trial. JAMA Cardiol. 2020 Apr 1;5(4):458-463. doi: 10.1001/jamacardio.2019.5963.

  PMID: 32074256 BACKGROUND

• Brouwer C, Hazekamp MG, Zeppenfeld K. Anatomical Substrates and Ablation of Reentrant Atrial and Ventricular Tachycardias in Repaired Congenital Heart Disease. Arrhythm Electrophysiol Rev. 2016 Aug;5(2):150-60. doi: 10.15420/AER.2016.19.2.

  PMID: 27617095 BACKGROUND

• Koyak Z, de Groot JR, Bouma BJ, Zwinderman AH, Silversides CK, Oechslin EN, Budts W, Van Gelder IC, Mulder BJ, Harris L. Sudden cardiac death in adult congenital heart disease: can the unpredictable be foreseen? Europace. 2017 Mar 1;19(3):401-406. doi: 10.1093/europace/euw060.

  PMID: 27247006 BACKGROUND

• Motonaga KS, Khairy P, Dubin AM. Electrophysiologic therapeutics in heart failure in adult congenital heart disease. Heart Fail Clin. 2014 Jan;10(1):69-89. doi: 10.1016/j.hfc.2013.09.011.

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  PMID: 29912584 BACKGROUND

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  PMID: 10483977 BACKGROUND

• Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.

  PMID: 28851729 BACKGROUND

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Defects, Congenital; Death, Sudden, Cardiac; Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Arrest; Death, Sudden; Death

Study Officials

• Antonio Berruezo, MD, PhD

  Centro Médico Teknon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Berruezo, MD, PhD

CONTACT

(+34)932906251; antonio.berruezo@quironsalud.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Arrhythmia Section

Study Record Dates

• First Submitted: August 8, 2021
• First Posted: December 1, 2021
• Study Start: April 7, 2021
• Primary Completion: April 30, 2024
• Study Completion: August 30, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)