LQT and Smartphone/Smartwatch

NCT ID: NCT04728100

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-22

Study Completion Date

2023-06-12

Brief Summary

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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.

Detailed Description

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Conditions

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Long QT Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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LQT

Patients with LQT syndrome diagnosis.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chevalier

Bron, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 38704288 (View on PubMed)

Other Identifiers

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69HCL20_1052

Identifier Type: -

Identifier Source: org_study_id

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