Use of the ECG Watch in Palpitation Assessment: Feasibility Study

NCT07121816 | Not Yet Recruiting

• 1 other identifier: AOI 2023 ABU ALRUB
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palpitation

Keywords

Palpitations; ScanWatch (Withings®); ECG

Outcome Measures

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)

  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.

  One month

• Average time to obtain a per critical trace

  One month

• Classification of recorded events

  One month

Study Arms (1)

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

Device: ECG watch

Interventions

ECG watch DEVICE

ECG watch in palpitation assessment

Patients using a 24-hour Holter ECG and a smartwatch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Hôpital Haut-Lévêque: collaborator
• University Hospital, Toulouse: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

Study Officials

• Saer ABU ALRUB

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise LACLAUTRE

CONTACT

+33473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

FR (1)