NCT06272396

Brief Summary

Over the past few years, various systems have been developed to record ECG traces on an ambulatory basis. The latest connected watch models feature 2-electrode ECG recording. This single (1D) or six derivations (6D) can be used to derive a wealth of information about the heart's rhythm. The information that can be derived from an ECG recording with a derivation goes far beyond̀ simple differentiation between atrial fibrillation and sinus rhythm. In contrast, in various clinical situations, a tracing restricted to an intracardiac defibrillator (ICD) may prove falsely normal, wrongly reassuring a patient and delaying management. The primary objective of the study is to evaluate the sensitivity of ECG-1D or 6D recordings from a connected watch in measuring electrical parameters, compared with a standard ECG-12D, also to obtain a bank of tracings, to create and validate an artificial intelligence algorithm for the automatic analysis of ECG tracings recorded with a connected watch and also to validate the feasibility and sensitivity of recording an ECG tracing with a connected watch in children.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
23mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Mar 2024Mar 2028

First Submitted

Initial submission to the registry

February 15, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

March 26, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2028

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

February 15, 2024

Last Update Submit

March 28, 2025

Conditions

Arrhythmias, Cardiac

Keywords

ElectrocardiogramSmart watchArrhythmiaArtificial IntelligentRemote monitoring

Outcome Measures

Primary Outcomes (5)

  • Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude

    Mean of P-wave amplitude

    36 months

  • Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration

    Mean of P-wave duration

    36 months

  • Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude

    Mean of QRS amplitude

    36 months

  • Comparison of electrical parameters measured using the 2 ECG methods: QRS duration

    Mean of QRS duration

    36 months

  • Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc

    Mean of QT/QTc (corrected QT) intervals

    36 months

Secondary Outcomes (5)

  • Creation of bank of anormal ECG trace

    36 months

  • Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG

    36 months

  • Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home

    36 months

  • Validate the feasibility of recording an ECG trace with a connected watch for a child

    36 months

  • Validate the sensibility of an ECG trace with a connected watch for a child

    36 months

Study Arms (1)

Smart watch

EXPERIMENTAL

ECG done with smart watch

Device: Smart watch

Interventions

Smart watchDEVICE

ECG 1D/6D

Smart watch

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients hospitalized or seen in consultation in one of the departments of the Haut Lévêque cardiology hospital,
  • Patient of both sexes, minor (from birth to 18 years) or adult,
  • Subject affiliated to or benefiting from a social security regime.

You may not qualify if:

  • Person incapable of giving consent,
  • Person subject to a legal protection measure (safeguard of justice, tutorship or curatorship),
  • A person deprived of liberty by judicial or administrative decision.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Haut-Lévèque

Pessac, 33604, France

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre BORDACHAR

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre BORDACHAR

CONTACT

+335 57 65 64 71pierre.bordachar@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2024

First Posted

February 22, 2024

Study Start

March 26, 2024

Primary Completion (Estimated)

March 26, 2027

Study Completion (Estimated)

March 26, 2028

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)