Heart DiseaseWAHOENCT06420960
Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG
A study testing Wearing the connected watch in people with Heart Disease, run by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône at 1 site in France.
Trial summary
Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department. Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease
- What is being tested?
- Wearing the connected watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2025to 17 Feb 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient consulting for the main reason of palpitations; without a previous diagnosis of arrhythmia, unless the current symptomatology appears different from that associated with the previous rythmological diagnosis;
- Palpitations requiring cardiological consultation or emergency hospital treatment;
- Absence of suggestive diagnosis on intercritical 12-lead ECG (pre-excitation, AVB M2/3, high-grade atrioventricular block, non-sustained tachyventricular, atrial fibrillation with heart rate; 110 per minute, atrial tachycardia or flutter);
- Non-contributory stress test (no electrical abnormality, occurrence of arrhythmia or reproduction of palpitations) if isymptoms occur during exercise;
- Accepts to wear the watch all the time outside the charging time;
- Using a personal smartphone or tablet compatible with the Health Mate application and with an Internet connection;
- Affiliated with a social security system ;
- Providing dated and signed an informed consent form.
Who cannot join
- Refusal to wear the connected watch;
- Refusal to use the watch provided for the study because they use a personal connected watch;
- Unable to use the connected watch (lack of understanding of its use and rationale);
- No smartphone;
- Wearer of an implantable device (PM, ICD);
- Already known and treated arrhythmia with identical symptoms;
Show all 13Show fewer
- Heart disease with indication for primary/secondary prevention implantable device;
- Associated syncope;
- Obvious extra-cardiac cause;
- Pregnant or breast-feeding woman;
- Inability to undergo study follow-up for geographical, linguistic, social or psychological reasons;
- Participating in another clinical study which can interfere with this study
- Patient under guardianship or deprived of liberty.
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
Hopitaux Nord-Ouest Villefranche Sur Saone
Gleizé, 69400
COLINE PERRIER, ARC, 0474092473 ext. +33, recherche@hno.fr
OLIVIER LE VAVASSEUR, MEDECINE
About this study
Official title: Rentabilité Diagnostique Des Montres connectées Par Rapport au Holter ECG Externe Dans l'Expertise Des Palpitations Fugaces Symptomatiques Sans Documentation électrocardiographique Per Critique.
Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department.
Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity.
Read more
The diagnostic difficulty lies in the frequency and duration of this transient symptom. At the time of consultation, the patient is often asymptomatic. The initial strategy is to demonstrate an electrocardiographic trace during the attack, in order to adapt management to the chosen etiology.
The HOLTER ECG is the gold standard, but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms.
The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms. They are widely adopted by the general population, with ease of use by the individual and long monitoring times.
The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies (rate of identification of the causal arrhythmia) at 6 months from the cardiological consultation.
- Conditions
- Heart Disease
- Being tested
- Wearing the connected watch
- Keywords
- palpitations, yield diagnostic, connected watch, device, HOLTER ECG, monitoring, profitability
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing the connected watchDevice
All patients will receive a connected watch from the research associate, along with instructions on its usage and support for creating an account on the Healtmate application using an anonymized e-mail address.
They will be able to transmit up to 3 ECG tracings deemed to be per-critical. A follow-up phone call at 2- months will assess understanding of the device and its proper use, as well as the occurrence of adverse events and compliance.
| Study group | Role | What they receive |
|---|---|---|
| connected watch | Experimental | All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study Receives: Device: Wearing the connected watch |
| HOLTER ECG 48 hours | Active comparator | All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study Receives: Device: Wearing the connected watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of diagnostic profitability of the connected watch compared with the conventional procedure (48-hour ECG Holter).
The investigators will compare the diagnostic performance of the connected watch with the HOLTER ECG, by identifying a symptomatic arrhythmia, , in the purpose of a faster and adapted cardiological management.
Measured: at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
Secondary outcomes (4)
Type of diagnosis recorded.
A diagnosis is defined by the documentation of an objective cardiac arrhythmia (focal atrial tachycardia/atrial fibrillation HR >110 bpm/atrial fibrillation HR<110 bpm/atrial flutter/junctional tachycardia/sustained or non-sustained ventricular tachycardia/peak tachycardia/sinus tachycardia/ventricular fibrillation/high-degree conduction disorder) concomitant with the symptomatology motivating the initial consultation.
Measured: at 6 months or when the watch is returned if a diagnosis has been made.
Rate of concomitant diagnoses with either device
Symptomatic objective cardiac arrythmia recorded with the smarwatch, the HOLTER or the both
Measured: at 6 months or when the watch is returned if a diagnosis has been made.
Rate of causal non-rhythmological diagnosis (symptoms without pathological per-critical ECG tracing)
Rate of ECGs failing to explain symptomatology (no ECG abnormality detected ECG) Time Frame : at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
Measured: at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
Medical/paramedical time per diagnosis and per patient
Fitting of holter ECG equipment, handover of watch and explanation of how it works, analysis of holter/ ECG tracings, reconsultation)
Measured: at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start15 Apr 2025
- Primary completion18 Jan 2027 (estimated)
- Study completion17 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420960
- Sponsor's protocol ID
- HNO23_0001
- Other IDs
- 2023-A01853-42
- Acronym
- WAHOE
- Status last verified
- Sep 2026
- First submitted
- 15 May 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Confidentiality and Privacy: Sharing IPD data could compromise the confidentiality and privacy of participants. Individual data, even anonymized, could potentially be used to identify individuals, particularly in the case of small cohorts or sensitive data. Data Sensitivity: IPD data includes sensitive health information. Sharing such data is subject to strict data protection regulations and requires additional measures to ensure security and confidentiality. Resources and Costs: Sharing IPD data requires additional resources for anonymization, management, and data provision. We do not have the necessary resources to perform these tasks due to our limited budget.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rentabilité Diagnostique Des Montres connectées Par Rapport au Holter ECG Externe Dans l'Expertise Des Palpitations Fugaces Symptomatiques Sans Documentation électrocardiographique Per Critique.
- ClinicalTrials.gov ID
- NCT06420960
- Acronym / sponsor ID
- WAHOE / HNO23_0001
- Conditions
- Heart Disease
- Keywords
- palpitations, yield diagnostic, connected watch, device, HOLTER ECG, monitoring, profitability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- L'hôpital Nord-Ouest - Villefranche Villefranche sur SaôneUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 17 Feb 2027 (estimated)
- First posted
- 20 May 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.
Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department.
Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity.
The diagnostic difficulty lies in the frequency and duration of this transient symptom. At the time of consultation, the patient is often asymptomatic. The initial strategy is to demonstrate an electrocardiographic trace during the attack, in order to adapt management to the chosen etiology.
The HOLTER ECG is the gold standard, but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms.
The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms. They are widely adopted by the general population, with ease of use by the individual and long monitoring times.
The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies (rate of identification of the causal arrhythmia) at 6 months from the cardiological consultation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| connected watch | Experimental | Device: Wearing the connected watchAll patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study |
| HOLTER ECG 48 hours | Active comparator | Device: Wearing the connected watchAll patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Any patient consulting for the main reason of palpitations; without a previous diagnosis of arrhythmia, unless the current symptomatology appears different from that associated with the previous rythmological diagnosis;
- Palpitations requiring cardiological consultation or emergency hospital treatment;
- Absence of suggestive diagnosis on intercritical 12-lead ECG (pre-excitation, AVB M2/3, high-grade atrioventricular block, non-sustained tachyventricular, atrial fibrillation with heart rate; 110 per minute, atrial tachycardia or flutter);
- Non-contributory stress test (no electrical abnormality, occurrence of arrhythmia or reproduction of palpitations) if isymptoms occur during exercise;
- Accepts to wear the watch all the time outside the charging time;
Key exclusion criteria (13 listed)
- Refusal to wear the connected watch;
- Refusal to use the watch provided for the study because they use a personal connected watch;
- Unable to use the connected watch (lack of understanding of its use and rationale);
- No smartphone;
- Wearer of an implantable device (PM, ICD);
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 |
|---|---|---|
| Wearing the connected watchAll patients will receive a connected watch from the research associate, along with instructions on its usage and support for creating an account on the Healtmate application using an anonymized e-mail address. They will be able to transmit up to 3 ECG tracings deemed to be per-critical. A follow-up phone call at 2- months will assess understanding of the device and its proper use, as well as the occurrence of adverse events and compliance. | Device | HOLTER ECG 48 hours, connected watch |
Primary outcome
Rate of diagnostic profitability of the connected watch compared with the conventional procedure (48-hour ECG Holter).
Time frame: at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
The investigators will compare the diagnostic performance of the connected watch with the HOLTER ECG, by identifying a symptomatic arrhythmia, , in the purpose of a faster and adapted cardiological management.
4 secondary outcomes
Type of diagnosis recorded.
Time frame: at 6 months or when the watch is returned if a diagnosis has been made.
Rate of concomitant diagnoses with either device
Time frame: at 6 months or when the watch is returned if a diagnosis has been made.
Rate of causal non-rhythmological diagnosis (symptoms without pathological per-critical ECG tracing)
Time frame: at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
Medical/paramedical time per diagnosis and per patient
Time frame: at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
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 29 Sep 2026.
- Individual participant dataSharing planned: Undecided. Confidentiality and Privacy: Sharing IPD data could compromise the confidentiality and privacy of participants. Individual data, even anonymized, could potentially be used to identify individuals, particularly in the case of small cohorts or sensitive data. Data Sensitivity: IPD data includes sensitive health information. Sharing such data is subject to strict data protection regulations and requires additional measures to ensure security and confidentiality. Resources and Costs: Sharing IPD data requires additional resources for anonymization, management, and data provision. We do not have the necessary resources to perform these tasks due to our limited budget.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing the connected watch in people with Heart Disease, run by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône 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 8 inclusion and 13 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 29 Sep 2026. 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 OLIVIER LE VAVASSEUR, MEDECINE (0474092753 ext. +33, olevavasseur@hno.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of diagnostic profitability of the connected watch compared with the conventional procedure (48-hour ECG Holter). (time frame: at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.). 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 29 Sep 2026.