Arrhythmias, CardiacNCT05140343
Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children
A study testing KARDIA Mobile ECG Monitoring (KMCM) in people with Arrhythmias, Cardiac and Children, Only, run by Centro Medico Teknon at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Arrhythmias, Cardiac, Children, Only, Congenital Heart Disease
- What is being tested?
- KARDIA Mobile ECG Monitoring (KMCM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSpain
- Study dates
- 7 Apr 2021to 30 Aug 2024
- Phase
- Interventional
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro Medico Teknon
Barcelona, 08022
Antonio Berruezo, MD, PhD, +34932906200, antonio.berruezo@quironsalud.es
Antonio Berruezo, MD, PhD
About this study
Official title: Effectiveness of Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children With Symptoms: A Randomized Clinical Trial
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.
Read the 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 electrocardiogram (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 smart phone, smart watch, or tablet. A recent 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.
- Conditions
- Arrhythmias, Cardiac, Children, Only, Congenital Heart Disease, Sudden Cardiac Death, Diagnoses Disease
- Being tested
- KARDIA Mobile ECG Monitoring (KMCM)
- Keywords
- grown ups with congenital heart (GUCH) disease, pediatric cardiology, diagnosis of arrhythmia, new diagnostic tools, early diagnosis, prevention
- Medical subject headings
- Arrhythmias, Cardiac, Heart Defects, Congenital, Death, Sudden, Cardiac, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile ECG Monitoring | Experimental | Standard care with clinical follow-up plus Mobile ECG Monitoring. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to a documented new arrhythmia.
Time to a documented new arrhythmia counting time from the inclusion date.
Measured: 12 months
Secondary outcomes (2)
Incidence of medical request
Rate of patients with changes of diagnostic and/or therapy
Measured: 12 months
Hospitalization during study time.
Number of participants hospitalized during study time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start7 Apr 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Medico Teknon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Berruezo, MD, PhD, Centro Medico Teknon
- Investigators
- Antonio Berruezo, MD, PhD, Principal investigator, Centro Médico Teknon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140343
- Sponsor's protocol ID
- SMART-CHILD
- Status last verified
- Aug 2023
- First submitted
- 8 Aug 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sherwin ED, Berul CI. Sudden Cardiac Death in Children and Adolescents. Card Electrophysiol Clin. 2017 Dec;9(4):569-579. doi: 10.1016/j.ccep.2017.07.008.
PubMed 29173403Buddhe 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.
PubMed 22452328Pappone C, Manguso F, Santinelli R, Vicedomini G, Sala S, Paglino G, Mazzone P, Lang CC, Gulletta S, Augello G, Santinelli O, Santinelli V. Radiofrequency ablation in children with asymptomatic Wolff-Parkinson-White syndrome. N Engl J Med. 2004 Sep 16;351(12):1197-205. doi: 10.1056/NEJMoa040625.
PubMed 15371577McCrank E, Schurmans K, Lefcoe D. Paroxysmal supraventricular tachycardia misdiagnosed as panic disorder. Arch Intern Med. 1998 Feb 9;158(3):297. doi: 10.1001/archinte.158.3.297. No abstract available.
PubMed 9472212Sedaghat-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.
PubMed 24267458Brignole 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.
PubMed 29562304MacCormick 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.
PubMed 19282063Johnson 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.
PubMed 24343729Sheldon R. Syncope outcomes in a national health database: low risk is not no risk. J Am Coll Cardiol. 2013 Jan 22;61(3):333-4. doi: 10.1016/j.jacc.2012.10.019. Epub 2012 Dec 12. No abstract available.
PubMed 23246387Nakano 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.
PubMed 29255503Longmuir 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.
PubMed 29345602von 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.
PubMed 32888682Sliwa 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.
PubMed 32074256Brouwer 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.
PubMed 27617095Koyak 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.
PubMed 27247006
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Electrocardiogram Monitoring for Detecting Arrhythmias in Children With Symptoms: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05140343
- Acronym / sponsor ID
- SMART-CHILD
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Centro Medico TeknonUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 1 Dec 2021 (actual)
- 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.
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.
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 electrocardiogram (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 smart phone, smart watch, or tablet. A recent 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile ECG Monitoring | Experimental | Diagnostic Test: KARDIA Mobile ECG Monitoring (KMCM)Standard care with clinical follow-up plus Mobile ECG Monitoring. |
| 24-hour Holter monitoring | No intervention | –Standard care with clinical follow-up plus repeating 24-hours Holter ECG (month 1, 6, 12) |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Diagnostic test | Mobile ECG Monitoring |
Primary outcome
Time to a documented new arrhythmia.
Time frame: 12 months
Time to a documented new arrhythmia counting time from the inclusion date.
2 secondary outcomes
Incidence of medical request
Time frame: 12 months
Hospitalization during study time.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 29173403Sherwin ED, Berul CI. Sudden Cardiac Death in Children and Adolescents. Card Electrophysiol Clin. 2017 Dec;9(4):569-579. doi: 10.1016/j.ccep.2017.07.008.
- Background: PubMed 22452328Buddhe 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.
- Background: PubMed 15371577Pappone C, Manguso F, Santinelli R, Vicedomini G, Sala S, Paglino G, Mazzone P, Lang CC, Gulletta S, Augello G, Santinelli O, Santinelli V. Radiofrequency ablation in children with asymptomatic Wolff-Parkinson-White syndrome. N Engl J Med. 2004 Sep 16;351(12):1197-205. doi: 10.1056/NEJMoa040625.
- Background: PubMed 9472212McCrank E, Schurmans K, Lefcoe D. Paroxysmal supraventricular tachycardia misdiagnosed as panic disorder. Arch Intern Med. 1998 Feb 9;158(3):297. doi: 10.1001/archinte.158.3.297. No abstract available.
- Background: PubMed 24267458Sedaghat-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.
- Background: PubMed 29562304Brignole 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.
- Background: PubMed 19282063MacCormick 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.
- Background: PubMed 24343729Johnson 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.
- Background: PubMed 23246387Sheldon R. Syncope outcomes in a national health database: low risk is not no risk. J Am Coll Cardiol. 2013 Jan 22;61(3):333-4. doi: 10.1016/j.jacc.2012.10.019. Epub 2012 Dec 12. No abstract available.
- Background: PubMed 29255503Nakano 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.
- Background: PubMed 29345602Longmuir 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.
- Background: PubMed 32888682von 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.
- Individual participant dataSharing planned: No
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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.
Antonio Berruezo, MD, PhD principal investigator
Centro Médico Teknon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KARDIA Mobile ECG Monitoring (KMCM) in people with Arrhythmias, Cardiac and Children, Only, run by Centro Medico Teknon at 1 site in Spain.
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 4 inclusion and 4 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 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Antonio Berruezo, MD, PhD ((+34)932906251, antonio.berruezo@quironsalud.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to a documented new arrhythmia. (time frame: 12 months). 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 NCT05140343, which also lists 19 linked publications.
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 31 Aug 2023.