LQT and Smartphone/Smartwatch

Completed

• Conditions: Long QT Syndrome

• Registration Number: NCT04728100
• Lead Sponsor: Hospices Civils de Lyon

Brief 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.

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

Not available

Study Timeline

• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-01-25
• Study First Posted: 2021-01-28
• Study Start: 2021-03-22
• Primary Completion: 2023-06-12
• Study Completion: 2023-06-12
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

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Exclusion Criteria

None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the heart rate (bpm).	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.
the duration of the QTc (ms)	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).	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.

Trial Locations

Locations (1)

Chevalier; 🇫🇷 Bron, France