Kardia Mobile for Detecting Arrhythmias in Children

Sponsor

Centro Medico Teknon (Other)

Overall Status

Recruiting

CT.gov ID

NCT05140343

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this project is to evaluate the Kardia Mobile capability 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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmias, Cardiac Children, Only Congenital Heart Disease Sudden Cardiac Death Diagnoses Disease	Diagnostic Test: Kardia Mobile ECG Monitoring (KMCM)	N/A

Detailed Description

Syncope and palpitation are one of the most common referrals to pediatric cardiology in patients with and without structural heart disease. In children with palpitation supraventricular tachycardia (SVT) is the most common final diagnosis. While some SVTs caused by the presence of an accessory pathway are highly recommend to be treated, other forms of arrhythmia are rarely life threatening and therapy depends on the burden of symptoms. Some SVT can be the first manifestation of an underlying heart disease. Early onset of atrial fibrillation, for example, in childhood usually reveals a genetic pathology and therefore needs further investigation. Besides the need for precise diagnosis to choose adequate management and therapy, unrecognized paroxysmal SVT have shown to lead to misdiagnosis mimicking symptoms of a psychiatric disorder. However, with the current diagnostic tools and protocols in only 10 % to 15 % of children with palpitation an underlying arrhythmia is found.

Syncope commonly is of benign character in children but it can be the first warning sign of a serious condition. Despite considerable testing and expense accurate diagnosis of the underlying cause of syncope is still challenging. The theoretical possibility of an underlying fatal arrhythmia adds remarkable to the mental health challenges of adolescence and the families. Sudden cardiac death (SCD) is a rare but devastating event in children and adolescents.

Syncope and palpitation deserve even higher attention in patients with congenital heart disease (CHD). These patients have an overall higher risk of developing cardiac arrhythmias as consequence of the pre-existing anatomical alterations, as well as the surgical treatment necessary for its correction. In many cases arrhythmia occur earlier in life and sometimes SCD is the first symptom of manifestation.

To study the origin of palpitation and syncope 12 lead ECG and 24-hours Holter monitoring is typically performed. In case of high clinical suspicion, implantable loop-recorder and electrophysiological study can be performed to finally reach a diagnosis. However, it is an invasive test that is thought to be avoided in children if possible and might be poorly tolerated in patients with CHD.

In recent years, technological development has allowed the validation of different tools for detection of arrhythmias by "smart" devices. The Kardia Mobile Cardiac Monitor is a handheld ECG device that enables users to collect and store single-channel ECG recordings using the smartphone, smartwatch, or tablet. The REHARSE-AF study, has demonstrated the efficacy of this device in the early diagnosis of arrhythmic disorders in adults by performing ECGs twice weekly plus additional ECG if symptomatic. However, its utility for the early detection and diagnosis of arrhythmias in children and patients with a CHD, which have a different normal physiology of the heart rhythm, has not yet been studied.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Effectiveness of Kardia Mobile for Detecting Arrhythmias in Children With Symptoms: A Randomized Clinical Trial

Actual Study Start Date :

Apr 7, 2021

Anticipated Primary Completion Date :

Apr 7, 2024

Anticipated Study Completion Date :

Aug 7, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Kardia Mobile ECG Monitoring (KMCM) Standard care with clinical follow-up plus Kardia Mobile ECG Monitoring.	Diagnostic Test: Kardia Mobile ECG Monitoring (KMCM) 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 an PDF 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.
No Intervention: 24-hour Holter monitoring Standard care with clinical follow-up plus repeating 24-hours Holter ECG (month 1, 6, 12)

Arm

Intervention/Treatment

Experimental: Kardia Mobile ECG Monitoring (KMCM)

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

Diagnostic Test: Kardia Mobile ECG Monitoring (KMCM)

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 an PDF 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.

No Intervention: 24-hour Holter monitoring

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

Outcome Measures

Primary Outcome Measures

Time to a documented new arrhythmia. [12 months]
Time to a documented new arrhythmia counting time from inclusiondate.

Secondary Outcome Measures

Incidence of medical request [12 months]
Rate of patients with changes of diagnostic and/or therapy
Hospitalization during study time. [12 months]
Number of paticipants hospitalized during study time

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 5-18 years old with or without the diagnosis of CHD and symptoms suggestive of rhythm disorders as follows: palpitations and/or syncope and/or dizziness.
24-hours Holter without diagnosis of arrhythmia.
Having an smartphone, smartwatch, or tablet (the patient itself or a family member who lives together with the patient) compatible with KMCM.
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.