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LQT and Smartphone/Smartwatch (SMART-QT)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Completed

Conditions

Long QT Syndrome

Treatments

Other: LQT

Study type

Observational

Funder types

Other

Identifiers

NCT04728100
69HCL20_1052

Details and patient eligibility

About

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.

Enrollment

111 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

Morel Elodie; Deliniere Antoine, MD

Data sourced from clinicaltrials.gov

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