Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07121816

Use of the ECG Watch in Palpitation Assessment: Feasibility 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

ECG watch

Device

ECG watch in palpitation assessment

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

    Time frame: One month

    Device events Cardiovascular events

Study contacts

Contact information is provided by the study sponsor or research team.

Lise LACLAUTRE

CONTACT

[email protected]

+33473754963

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Hôpital Haut-Lévêque
  • University Hospital, Toulouse

Registry information

Acronym: WATCH-RHYTHM

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2025
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.