NCT07121816

Use of the ECG Watch in Palpitation Assessment: Feasibility Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	ECG watch	ECG watch in palpitation assessment

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-09-01
• Completion: 2028-09-01
• First posted: 2025-08-14
• Last updated: 2025-08-14

Locations

1 site across 1 country: France