Long QT SyndromeSMART-QTNCT04728100
LQT and Smartphone/Smartwatch
An observational study of Long QT Syndrome, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Congenital long QT syndrome (LQTS) is a rare genetic disorder characterized by prolongation of the corrected QT interval (QTc) on the electrocardiogram. LQTS is associated with a risk of syncope or sudden death from ventricular arrhythmia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Long QT Syndrome
- What is being tested?
- LQT
- How many people
- 111 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2021to 12 Jun 2023
- 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: LQT patients
Who may be able to join
- Patient with diagnosis of LQTS based on the following criteria:
- Corrected QT (Qtc) interval according to Bazett method ≥ 480 ms, at several times in the absence of a secondary cause
- and / or class 4 or 5 mutation in a gene involved in long QT syndrome
- and / or syncope (s) and QTc> 460ms in the absence of other cause
- All ages
- No opposition from the patient
Who cannot join
- None
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Smartphone and Smartwatch Based ECG for Patients With Congenital Long QT Syndrome
Congenital long QT syndrome (LQTS) is a rare genetic disorder characterized by prolongation of the corrected QT interval (QTc) on the electrocardiogram. LQTS is associated with a risk of syncope or sudden death from ventricular arrhythmia.
The increase in the duration of the corrected QT interval and / or changes in the morphology of the T wave on the electrocardiogram are markers of an increased risk of sudden death and syncope.
Read more
Recently, a personal portable 6-lead device (DI, DII, DIII, aVF, aVL and aVR) connected to the patient's smartphone has entered the market (KARDIA MOBILE 6L, AliveCor, Mountain View, CALIFORNIA, USA). The APPLE WATCH Series 6 (Apple, Cupertino, CA, USA) can also record an ECG. If the device is designed to record a single lead (DI), several works have shown that it is possible to record 9 leads (DI, DII, DIII, V1, V2, V3, V4, V5 and V6) by moving simply the device (Spaccarotella CAS et al. JAMA Cardiology 2020).
These devices were originally designed to screen for atrial fibrillation, but they produce accurate 6- and 9-lead ECGs and could potentially allow ambulatory ECG monitoring of patients with LQTS.
- Conditions
- Long QT Syndrome
- Being tested
- LQT
- Medical subject headings
- Long QT Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LQTOther
Patients with LQT syndrome diagnosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of the QTc (ms)
The primary outcome is the measurement of 3 data:
- the duration of the QTc (ms). These data will be measured during the same inclusion visit with 1/ the standard 12-lead ECG machine, 2/ the KARDIA MOBILE 6L and 3/the APPLE WATCH Series 6. The data of the Kardia Mobile 6L and the Apple Watch series 6 will be compared to the data of the gold standard a 12-lead ECG.
Measured: at the inclusion visit
the morphology of the T waves (bpm).
- the morphology of the T waves (bpm). These data will be measured during the same inclusion visit with 1/ the standard 12-lead ECG machine, 2/ the KARDIA MOBILE 6L and 3/the APPLE WATCH Series 6. The data of the Kardia Mobile 6L and the Apple Watch series 6 will be compared to the data of the gold standard a 12-lead ECG.
Measured: at the inclusion visit
the heart rate (bpm).
- the heart rate (bpm). These data will be measured during the same inclusion visit with 1/ the standard 12-lead ECG machine, 2/ the KARDIA MOBILE 6L and 3/the APPLE WATCH Series 6. The data of the Kardia Mobile 6L and the Apple Watch series 6 will be compared to the data of the gold standard a 12-lead ECG.
Measured: at the inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start22 Mar 2021
- Primary completion12 Jun 2023
- Study completion12 Jun 2023
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 Long QT SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04728100
- Sponsor's protocol ID
- 69HCL20_1052
- Acronym
- SMART-QT
- Status last verified
- Nov 2023
- First submitted
- 21 Jan 2021
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Deliniere A, Bessiere F, Placide L, Pasquie JL, Haddad C, Tirel S, Mokhtar H, Morel E, Gardey K, Dulac A, Ditac G, Sacher F, Denjoy I, Chevalier P. Wearable electrocardiogram devices in patients with congenital long QT syndrome: The SMART-QT study. Arch Cardiovasc Dis. 2024 May;117(5):313-320. doi: 10.1016/j.acvd.2024.02.010. Epub 2024 Apr 24.
PubMed 38704288
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone and Smartwatch Based ECG for Patients With Congenital Long QT Syndrome
- ClinicalTrials.gov ID
- NCT04728100
- Acronym / sponsor ID
- SMART-QT / 69HCL20_1052
- Conditions
- Long QT Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 12 Jun 2023 (actual)
- Study completion
- 12 Jun 2023 (actual)
- First posted
- 28 Jan 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.
Congenital long QT syndrome (LQTS) is a rare genetic disorder characterized by prolongation of the corrected QT interval (QTc) on the electrocardiogram. LQTS is associated with a risk of syncope or sudden death from ventricular arrhythmia.
The increase in the duration of the corrected QT interval and / or changes in the morphology of the T wave on the electrocardiogram are markers of an increased risk of sudden death and syncope.
Recently, a personal portable 6-lead device (DI, DII, DIII, aVF, aVL and aVR) connected to the patient's smartphone has entered the market (KARDIA MOBILE 6L, AliveCor, Mountain View, CALIFORNIA, USA). The APPLE WATCH Series 6 (Apple, Cupertino, CA, USA) can also record an ECG. If the device is designed to record a single lead (DI), several works have shown that it is possible to record 9 leads (DI, DII, DIII, V1, V2, V3, V4, V5 and V6) by moving simply the device (Spaccarotella CAS et al. JAMA Cardiology 2020).
These devices were originally designed to screen for atrial fibrillation, but they produce accurate 6- and 9-lead ECGs and could potentially allow ambulatory ECG monitoring of patients with LQTS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- LQT patients
Key inclusion criteria (6 listed)
- Corrected QT (Qtc) interval according to Bazett method ≥ 480 ms, at several times in the absence of a secondary cause
- and / or class 4 or 5 mutation in a gene involved in long QT syndrome
- and / or syncope (s) and QTc> 460ms in the absence of other cause
Key exclusion criteria (2 listed)
- None
- -
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 |
|---|---|---|
| LQTPatients with LQT syndrome diagnosis. | Other | – |
Primary outcome
the duration of the QTc (ms)
Time frame: at the inclusion visit
The primary outcome is the measurement of 3 data: - the duration of the QTc (ms). These data will be measured during the same inclusion visit with 1/ the standard 12-lead ECG machine, 2/ the KARDIA MOBILE 6L and 3/the APPLE WATCH Series 6. The data of the Kardia Mobile 6L and the Apple Watch series 6 will be compared to the data of the gold standard a 12-lead ECG.
the morphology of the T waves (bpm).
Time frame: at the inclusion visit
- the morphology of the T waves (bpm). These data will be measured during the same inclusion visit with 1/ the standard 12-lead ECG machine, 2/ the KARDIA MOBILE 6L and 3/the APPLE WATCH Series 6. The data of the Kardia Mobile 6L and the Apple Watch series 6 will be compared to the data of the gold standard a 12-lead ECG.
the heart rate (bpm).
Time frame: at the inclusion visit
- the heart rate (bpm). These data will be measured during the same inclusion visit with 1/ the standard 12-lead ECG machine, 2/ the KARDIA MOBILE 6L and 3/the APPLE WATCH Series 6. The data of the Kardia Mobile 6L and the Apple Watch series 6 will be compared to the data of the gold standard a 12-lead ECG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 38704288Deliniere A, Bessiere F, Placide L, Pasquie JL, Haddad C, Tirel S, Mokhtar H, Morel E, Gardey K, Dulac A, Ditac G, Sacher F, Denjoy I, Chevalier P. Wearable electrocardiogram devices in patients with congenital long QT syndrome: The SMART-QT study. Arch Cardiovasc Dis. 2024 May;117(5):313-320. doi: 10.1016/j.acvd.2024.02.010. Epub 2024 Apr 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long QT Syndrome, run by Hospices Civils de Lyon at 1 site in France.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 7 Nov 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the duration of the QTc (ms) (time frame: at the inclusion visit). The study lists 3 primary outcomes in all. 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 NCT04728100, 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 7 Nov 2023.