LQT and Smartphone/Smartwatch

NCT04728100 | Completed

• 1 other identifier: 69HCL20_1052
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Long QT Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  at the inclusion visit

Interventions

LQT OTHER

Patients with LQT syndrome diagnosis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

LQT patients

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Chevalier

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 38704288 DERIVED

MeSH Terms

Conditions

Long QT Syndrome

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 28, 2021
• Study Start: March 22, 2021
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

FR (1)