LQT and Smartphone/Smartwatch (SMART-QT)

November 6, 2023 updated by: Hospices Civils de Lyon

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Chevalier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

LQT patients

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at the inclusion visit
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.
at the inclusion visit
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.
at the inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

June 12, 2023

Study Completion (Actual)

June 12, 2023

Study Registration Dates

First Submitted

January 21, 2021

First Submitted That Met QC Criteria

January 25, 2021

First Posted (Actual)

January 28, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_1052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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