Use of the ECG Watch in Palpitation Assessment: Feasibility Study

NCT ID: NCT07121816

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-09-01

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ECG watch

Intervention Type: DEVICE

ECG watch in palpitation assessment

Interventions

ECG watch

ECG watch in palpitation assessment

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Haut-Lévêque

OTHER

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Saer ABU ALRUB

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise LACLAUTRE

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

+33473754963

Other Identifiers

AOI 2023 ABU ALRUB

Identifier Type: -

Identifier Source: org_study_id