Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

NCT ID: NCT06420960

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2027-02-17

Brief Summary

Palpitations are a frequent reason for consultation (16% of total volume) and management in the emergency department.

Conventional diagnostic management in our establishment is based on a 48-hour external ECG holter, combined with a stress test if symptoms are triggered by physical activity.

The diagnostic difficulty lies in the frequency and duration of this transient symptom. At the time of consultation, the patient is often asymptomatic. The initial strategy is to demonstrate an electrocardiographic trace during the attack, in order to adapt management to the chosen etiology.

The HOLTER ECG is the gold standard, but it is not very cost-effective due to the infrequent and random nature of the onset of symptoms.

The advent of accessible connected tools such as connected watches seems to be an interesting alternative for acquiring a per-critical trace of symptoms. They are widely adopted by the general population, with ease of use by the individual and long monitoring times.

The main aim of the study is to establish the diagnostic cost-effectiveness of one or other of the two diagnostic strategies (rate of identification of the causal arrhythmia) at 6 months from the cardiological consultation.

Conditions

Heart Disease

Study Design

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

Study Groups

connected watch

All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study

Group Type: EXPERIMENTAL

Wearing the connected watch

Intervention Type: DEVICE

All patients will receive a connected watch from the research associate, along with instructions on its usage and support for creating an account on the Healtmate application using an anonymized e-mail address.

They will be able to transmit up to 3 ECG tracings deemed to be per-critical. A follow-up phone call at 2- months will assess understanding of the device and its proper use, as well as the occurrence of adverse events and compliance.

HOLTER ECG 48 hours

All patients will be equipped by HOLTER for 48-hour monitoring, with an event form to be filled in, at the same time as receiving a connected watch for a 6 -months period. They will be asked to record an ECG with the watch only when they experience symptoms that have included them in the study

Group Type: ACTIVE_COMPARATOR

Wearing the connected watch

Intervention Type: DEVICE

All patients will receive a connected watch from the research associate, along with instructions on its usage and support for creating an account on the Healtmate application using an anonymized e-mail address.

They will be able to transmit up to 3 ECG tracings deemed to be per-critical. A follow-up phone call at 2- months will assess understanding of the device and its proper use, as well as the occurrence of adverse events and compliance.

Interventions

Wearing the connected watch

All patients will receive a connected watch from the research associate, along with instructions on its usage and support for creating an account on the Healtmate application using an anonymized e-mail address.

They will be able to transmit up to 3 ECG tracings deemed to be per-critical. A follow-up phone call at 2- months will assess understanding of the device and its proper use, as well as the occurrence of adverse events and compliance.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Any patient consulting for the main reason of palpitations; without a previous diagnosis of arrhythmia, unless the current symptomatology appears different from that associated with the previous rythmological diagnosis;
• Palpitations requiring cardiological consultation or emergency hospital treatment;
• Absence of suggestive diagnosis on intercritical 12-lead ECG (pre-excitation, AVB M2/3, high-grade atrioventricular block, non-sustained tachyventricular, atrial fibrillation with heart rate; 110 per minute, atrial tachycardia or flutter);
• Non-contributory stress test (no electrical abnormality, occurrence of arrhythmia or reproduction of palpitations) if isymptoms occur during exercise;
• Accepts to wear the watch all the time outside the charging time;
• Using a personal smartphone or tablet compatible with the Health Mate application and with an Internet connection;
• Affiliated with a social security system ;
• Providing dated and signed an informed consent form.

Exclusion Criteria

• Refusal to wear the connected watch;
• Refusal to use the watch provided for the study because they use a personal connected watch;
• Unable to use the connected watch (lack of understanding of its use and rationale);
• No smartphone;
• Wearer of an implantable device (PM, ICD);
• Already known and treated arrhythmia with identical symptoms;
• Heart disease with indication for primary/secondary prevention implantable device;
• Associated syncope;
• Obvious extra-cardiac cause;
• Pregnant or breast-feeding woman;
• Inability to undergo study follow-up for geographical, linguistic, social or psychological reasons;
• Participating in another clinical study which can interfere with this study
• Patient under guardianship or deprived of liberty.

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

Sponsors

L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopitaux Nord-Ouest Villefranche Sur Saone

Gleizé, , France

Site Status: RECRUITING

Countries

France

Central Contacts

OLIVIER LE VAVASSEUR, MEDECINE

Role: CONTACT

olevavasseur@hno.fr

0474092753 ext. +33

COLINE PERRIER, ARC

Role: CONTACT

cperrier@hno.fr

0474092473 ext. +33

Facility Contacts

COLINE PERRIER, ARC

Role: primary

recherche@hno.fr

0474092473 ext. +33

Other Identifiers

2023-A01853-42

Identifier Type: OTHER

Identifier Source: secondary_id

HNO23_0001

Identifier Type: -

Identifier Source: org_study_id