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Not yet recruitingNCT07121816WATCH-RHYTHMUpdated Aug 14, 2025

Use of the ECG Watch in Palpitation Assessment: Feasibility Study

An interventional study of ECG watch in Palpitation, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Palpitation

Keywords

  • Palpitations
  • ScanWatch (Withings®)
  • ECG
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion criteria :

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Patients using a 24-hour Holter ECG and a smartwatch

    A single group of patients, all using a 24-hour Holter ECG and a smartwatch

    Device: ECG watch

Interventions

  • DeviceECG watch

    ECG watch in palpitation assessment

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Average number of traces per critical necessary to obtain an interpretable trace with the Spider Flash and the connected watch.

    Time frame: One month

  2. Average time to obtain a per critical trace

    Time frame: One month

  3. Classification of recorded events

    Device events Cardiovascular events

    Time frame: One month

07

Study locations

1 site
  • CHU Clermont-Ferrand
    Clermont-Ferrand, 63000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07121816
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
Hôpital Haut-Lévêque, University Hospital, Toulouse
Responsible party
Sponsor
First posted
Aug 14, 2025
Start date
Sep 1, 2025 (estimated)
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Aug 14, 2025

Study contacts

Lise LACLAUTRE
Contact
promo_interne_drci@chu-clermontferrand.fr
+33473754963
Saer ABU ALRUB
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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