Arrhythmias, CardiacECG-MCNCT06272396
Relevance of Recording an ECG Trace With a Connected Watch
A study testing Smart watch in people with Arrhythmias, Cardiac, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arrhythmias, Cardiac
- What is being tested?
- Smart watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2024to 26 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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,
- Free, informed and written consent from the patient or, in the case of minors, from the legal parent (at the latest on the day of inclusion and before any examination required for the research),
- Subject affiliated to or benefiting from a social security regime.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Haut-Lévèque
Pessac, 33604
Pierre BORDACHAR
About this study
Official title: Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
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.
Read the detailed description
Single-arm prospective study to evaluate the measurement of electrocardiographic parameters obtained using two non-invasive ECG methods, one 12-lead reference method and the second 1 or 6 leads recorded from a connected watch, in a group of patients with healthy hearts (normal ECG) and 19 pathological groups.
- Conditions
- Arrhythmias, Cardiac
- Being tested
- Smart watch
- Keywords
- Electrocardiogram, Smart watch, Arrhythmia, Artificial Intelligent, Remote monitoring
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart watchDevice
ECG 1D/6D
| Study group | Role | What they receive |
|---|---|---|
| Smart watch | Experimental | ECG done with smart watch Receives: Device: Smart watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude
Mean of P-wave amplitude
Measured: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration
Mean of P-wave duration
Measured: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude
Mean of QRS amplitude
Measured: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: QRS duration
Mean of QRS duration
Measured: 36 months
Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc
Mean of QT/QTc (corrected QT) intervals
Measured: 36 months
Secondary outcomes (5)
Creation of bank of anormal ECG trace
Number of ECG-1D/6D and 12 derivations
Measured: 36 months
Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG
Accuracy of diagnostic
Measured: 36 months
Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home
Number of ECG-1D/6D and 12 derivations
Measured: 36 months
Validate the feasibility of recording an ECG trace with a connected watch for a child
Number of ECG-1D/6D and 12 derivations
Measured: 36 months
Validate the sensibility of an ECG trace with a connected watch for a child
Quality of ECG-1D/6D
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start26 Mar 2024
- Primary completion26 Mar 2027 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre BORDACHAR, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272396
- Sponsor's protocol ID
- CHUBX 2023/64
- Acronym
- ECG-MC
- Status last verified
- Mar 2025
- First submitted
- 15 Feb 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Diagnostic Relevance of Recording an ECG Trace With a Connected Watch
- ClinicalTrials.gov ID
- NCT06272396
- Acronym / sponsor ID
- ECG-MC / CHUBX 2023/64
- Conditions
- Arrhythmias, Cardiac
- Keywords
- Electrocardiogram, Smart watch, Arrhythmia, Artificial Intelligent, Remote monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Single-arm prospective study to evaluate the measurement of electrocardiographic parameters obtained using two non-invasive ECG methods, one 12-lead reference method and the second 1 or 6 leads recorded from a connected watch, in a group of patients with healthy hearts (normal ECG) and 19 pathological groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smart watch | Experimental | Device: Smart watchECG done with smart watch |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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,
- Free, informed and written consent from the patient or, in the case of minors, from the legal parent (at the latest on the day of inclusion and before any examination required for the research),
- Subject affiliated to or benefiting from a social security regime.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart watchECG 1D/6D | Device | Smart watch |
Primary outcome
Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude
Time frame: 36 months
Mean of P-wave amplitude
Comparison of electrical parameters measured using the 2 ECG methods: P-wave duration
Time frame: 36 months
Mean of P-wave duration
Comparison of electrical parameters measured using the 2 ECG methods: QRS amplitude
Time frame: 36 months
Mean of QRS amplitude
Comparison of electrical parameters measured using the 2 ECG methods: QRS duration
Time frame: 36 months
Mean of QRS duration
Comparison of electrical parameters measured using the 2 ECG methods: QT/QTc
Time frame: 36 months
Mean of QT/QTc (corrected QT) intervals
5 secondary outcomes
Creation of bank of anormal ECG trace
Time frame: 36 months
Compare the diagnostic capabilities of an ECG trace recorded with a watch against the reference method, the 12-lead ECG
Time frame: 36 months
Validate the feasibility of recording and sending of ECG tracings with a connected watch at the patient's home
Time frame: 36 months
Validate the feasibility of recording an ECG trace with a connected watch for a child
Time frame: 36 months
Validate the sensibility of an ECG trace with a connected watch for a child
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre BORDACHAR principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart watch in people with Arrhythmias, Cardiac, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre BORDACHAR (+335 57 65 64 71, pierre.bordachar@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of electrical parameters measured using the 2 ECG methods: P-wave amplitude (time frame: 36 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.