PalpitationWATCH-RHYTHMNCT07121816
Use of the ECG Watch in Palpitation Assessment: Feasibility Study
A study testing ECG watch in people with Palpitation, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Palpitations are the cause of 16% of reasons for consultation with the general practitioner. 41% of palpitations are secondary to cardiac arrhythmia. If a rhythm or conduction disorder is recorded in a symptomatic context, then the cardiac origin can be validated or invalidated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palpitation
- What is being tested?
- ECG watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 1 Sep 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient, male or female, referred for cardiological consultation for assessment of palpitations, after which an outpatient electrocardiographic exploration is carried out by the cardiologist.
- - Patient presenting at least 1 palpitation attack per month over the last 3 months or at least 1 palpitation attack per week over the last month.
- Patient equipped with a smartphone compatible with the HealthMate application.
- Able to give consent to participate in research.
- Affiliation to a social security regime.
Who cannot join
- Patient physically or mentally unable to make a recording using the connected watch.
- Patient contraindicated for the application of skin patches.
- Patient with pacemaker or defibrillator.
- Pregnant or breastfeeding women
- Patients of legal age under protective supervision
- Refusal to participate
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Palpitations are the cause of 16% of reasons for consultation with the general practitioner. 41% of palpitations are secondary to cardiac arrhythmia. If a rhythm or conduction disorder is recorded in a symptomatic context, then the cardiac origin can be validated or invalidated. The challenge therefore consists of obtaining an ECG trace during an attack of palpitations (per-critical ECG). Since patients are rarely symptomatic during consultations, additional exploration by ambulatory electrocardiographic recording is essential. To date, the 24-hour Holter ECG is currently the most used in current practice, only has a sensitivity of 22 to 35% maximum depending on the studies. We hypothesize that the ECG watch is a reliable medical tool in the etiological assessment of palpitations, with at least 90% of traces interpretable.
The main objective of this study is to validate the use of the ScanWatch watch (Withings®) in the assessment of palpitations.
Read the detailed description
The following examinations will be carried out:
- After inclusion: Information on the operation of the connected watch, loan of the watch, and implementation of a 14-day Spider Flash.
- For a minimum of 14 days to 1 month, the patient will wear the connected watch, and activate it during an attack of palpitations. For 14 days, he will be concomitantly equipped with a Spider Flash.
- All of the watch's traces will be automatically transferred to the Withings RPM data visualization platform independent of each center. The traces will then be centralized anonymously to analyze the results.
- At the end of the loan period, the patient then returns the watch to the cardiology department of their reference center. The Spider Flash is removed after 14 days.
- The patient will be summoned to carry out additional examinations or make therapeutic modifications according to the results of these examinations as part of routine care by their reference center.
- Conditions
- Palpitation
- Being tested
- ECG watch
- Keywords
- Palpitations, ScanWatch (Withings®), ECG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG watchDevice
ECG watch in palpitation assessment
| Study group | Role | What they receive |
|---|---|---|
| Patients using a 24-hour Holter ECG and a smartwatch | Experimental | A single group of patients, all using a 24-hour Holter ECG and a smartwatch Receives: Device: ECG watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between the number of per-critical tracings obtained via the connected watch (explanatory variable) and the number of interpretable tracings obtained (dependent variable)
Measured: One month
Secondary outcomes (3)
Average number of traces per critical necessary to obtain an interpretable trace with the Spider Flash and the connected watch.
Measured: One month
Average time to obtain a per critical trace
Measured: One month
Classification of recorded events
Device events Cardiovascular events
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PalpitationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ScanWatch (Withings®) For a minimum of 14 days to 1 month, the patient will wear the connected watch, and activate it during an attack of palpitations. For 14 days, he will be concomitantly equipped with a Spider Flash.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Haut-Lévêque, University Hospital, Toulouse
- Responsible party
- Sponsor
- Investigators
- Saer ABU ALRUB, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121816
- Sponsor's protocol ID
- AOI 2023 ABU ALRUB
- Acronym
- WATCH-RHYTHM
- Status last verified
- Aug 2025
- First submitted
- 26 Jun 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the ECG Watch in Palpitation Assessment: Feasibility Study
- ClinicalTrials.gov ID
- NCT07121816
- Acronym / sponsor ID
- WATCH-RHYTHM / AOI 2023 ABU ALRUB
- Conditions
- Palpitation
- Keywords
- Palpitations, ScanWatch (Withings®), ECG
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Hôpital Haut-Lévêque, University Hospital, Toulouse
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 14 Aug 2025 (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 the cause of 16% of reasons for consultation with the general practitioner. 41% of palpitations are secondary to cardiac arrhythmia. If a rhythm or conduction disorder is recorded in a symptomatic context, then the cardiac origin can be validated or invalidated. The challenge therefore consists of obtaining an ECG trace during an attack of palpitations (per-critical ECG). Since patients are rarely symptomatic during consultations, additional exploration by ambulatory electrocardiographic recording is essential. To date, the 24-hour Holter ECG is currently the most used in current practice, only has a sensitivity of 22 to 35% maximum depending on the studies. We hypothesize that the ECG watch is a reliable medical tool in the etiological assessment of palpitations, with at least 90% of traces interpretable.
The main objective of this study is to validate the use of the ScanWatch watch (Withings®) in the assessment of palpitations.
Detailed description
The following examinations will be carried out:
- After inclusion: Information on the operation of the connected watch, loan of the watch, and implementation of a 14-day Spider Flash.
- For a minimum of 14 days to 1 month, the patient will wear the connected watch, and activate it during an attack of palpitations. For 14 days, he will be concomitantly equipped with a Spider Flash.
- All of the watch's traces will be automatically transferred to the Withings RPM data visualization platform independent of each center. The traces will then be centralized anonymously to analyze the results.
- At the end of the loan period, the patient then returns the watch to the cardiology department of their reference center. The Spider Flash is removed after 14 days.
- The patient will be summoned to carry out additional examinations or make therapeutic modifications according to the results of these examinations as part of routine care by their reference center.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ScanWatch (Withings®) For a minimum of 14 days to 1 month, the patient will wear the connected watch, and activate it during an attack of palpitations. For 14 days, he will be concomitantly equipped with a Spider Flash.
| Arm | Type | Receives |
|---|---|---|
| Patients using a 24-hour Holter ECG and a smartwatch | Experimental | Device: ECG watchA single group of patients, all using a 24-hour Holter ECG and a smartwatch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient, male or female, referred for cardiological consultation for assessment of palpitations, after which an outpatient electrocardiographic exploration is carried out by the cardiologist.
- - Patient presenting at least 1 palpitation attack per month over the last 3 months or at least 1 palpitation attack per week over the last month.
- Patient equipped with a smartphone compatible with the HealthMate application.
- Able to give consent to participate in research.
- Affiliation to a social security regime.
Key exclusion criteria (6 listed)
- Patient physically or mentally unable to make a recording using the connected watch.
- Patient contraindicated for the application of skin patches.
- Patient with pacemaker or defibrillator.
- Pregnant or breastfeeding women
- Patients of legal age under protective supervision
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 |
|---|---|---|
| ECG watchECG watch in palpitation assessment | Device | Patients using a 24-hour Holter ECG and a smartwatch |
Primary outcome
Concordance between the number of per-critical tracings obtained via the connected watch (explanatory variable) and the number of interpretable tracings obtained (dependent variable)
Time frame: One month
3 secondary outcomes
Average number of traces per critical necessary to obtain an interpretable trace with the Spider Flash and the connected watch.
Time frame: One month
Average time to obtain a per critical trace
Time frame: One month
Classification of recorded events
Time frame: One month
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 14 Aug 2025.
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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.
Saer ABU ALRUB principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG watch in people with Palpitation, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Aug 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 Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance between the number of per-critical tracings obtained via the connected watch (explanatory variable) and the number of interpretable tracings obtained (dependent variable) (time frame: One month). 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 14 Aug 2025.