Use of the ECG Watch in Palpitation Assessment: Feasibili... | NCT07121816

Studies
Use of the ECG Watch in Palpitation Assessment: Feasibility Study

NCT07121816

Sponsor

University Hospital, Clermont-Ferrand

Status

Not yet recruiting

Last Update Posted

Aug 14, 2025Actual

Enrollment

120Estimated

Phase

Not Applicable

Conditions

Palpitation

Interventions

ECG watch

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Sep 1, 2027Estimated

Completion Date

Sep 1, 2028Estimated

First Submitted Date

Jun 26, 2025

First Submission Date that Met QC Criteria

Aug 7, 2025

First Posted Date

Aug 14, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2025

Last Update Posted Date

Aug 14, 2025Actual

Name	Class
Hôpital Haut-Lévêque	OTHER
University Hospital, Toulouse	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ECG watch	Device	ECG watch in palpitation assessment	Patients using a 24-hour Holter ECG and a smartwatch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise LACLAUTRE	Contact	+33473754963		promo_interne_drci@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Saer ABU ALRUB	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand		Clermont-Ferrand		63000	France

Intervention Model Description

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.