Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG

Heart Disease Clinical Trial

— WAHOE  

Official title:

Rentabilité Diagnostique Des Montres connectées Par Rapport au Holter ECG Externe Dans l'Expertise Des Palpitations Fugaces Symptomatiques Sans Documentation électrocardiographique Per Critique.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420960
• Other study ID #: HNO23_0001
• Secondary ID: 2023-A01853-42
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 17, 2024
• Est. completion date: February 17, 2027

Study information

• Verified date: May 2024
• Source: L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône
• Contact: OLIVIER LE VAVASSEUR, MEDECINE
• Phone: 0474092753
• Email: olevavasseur[@]hno.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 81
• Est. completion date: February 17, 2027
• Est. primary completion date: January 18, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Disease
• Heart Diseases

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Hopitaux Nord-Ouest Villefranche Sur Saone	Gleize

Sponsors (1)

Lead Sponsor	Collaborator
L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of diagnostic profitability of the connected watch compared with the conventional procedure (48-hour ECG Holter).	We will compare the diagnostic performance of the connected watch with the HOLTER ECG, by identifying a symptomatic arrhythmia, , in the purpose of a faster and adapted cardiological management.	at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
Secondary	Type of diagnosis recorded.	A diagnosis is defined by the documentation of an objective cardiac arrhythmia (focal atrial tachycardia/atrial fibrillation HR >110 bpm/atrial fibrillation HR<110 bpm/atrial flutter/junctional tachycardia/sustained or non-sustained ventricular tachycardia/peak tachycardia/sinus tachycardia/ventricular fibrillation/high-degree conduction disorder) concomitant with the symptomatology motivating the initial consultation.	at 6 months or when the watch is returned if a diagnosis has been made.
Secondary	Rate of concomitant diagnoses with either device	Symptomatic objective cardiac arrythmia recorded with the smarwatch, the HOLTER or the both	at 6 months or when the watch is returned if a diagnosis has been made.
Secondary	Rate of causal non-rhythmological diagnosis (symptoms without pathological per-critical ECG tracing)	Rate of ECGs failing to explain symptomatology (no ECG abnormality detected ECG) Time Frame : at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.	at 6 months or when the watch is returned if a diagnosis has been made or if there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.
Secondary	Medical/paramedical time per diagnosis and per patient	Fitting of holter ECG equipment, handover of watch and explanation of how it works, analysis of holter/ ECG tracings, reconsultation)	at 6 months or when the watch is returned, whether a diagnosis has been made or whether there have been 3 ECG transmissions that did not reveal any cardiac arrhythmia.