Actively Recruiting
Diagnostic Cost-Effectiveness of Connected Watch ECG Compared to 48-Hour External Holter ECG for Symptomatic Palpitations Without Electrocardiographic Documentation
Led by L'hôpital Nord-Ouest - Villefranche Villefranche sur Saône · Updated on 2025-04-08
81
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic effectiveness and cost efficiency of using connected watch ECG monitoring compared to the conventional 48-hour external Holter ECG for patients experiencing palpitations without documented electrocardiographic traces. Palpitations are a common reason for emergency consultations, but their transient and infrequent nature makes diagnosis challenging. This study aims to compare how well these two strategies identify the cause of arrhythmias six months after cardiological consultation. All participants will wear a standard 48-hour Holter ECG monitor and also receive a connected watch for a six-month period. They will be instructed to record ECG tracings with the connected watch only when experiencing symptoms. The Holter ECG records continuously for 48 hours, while the watch provides extended monitoring and allows up to three symptom-triggered ECG transmissions. Participants will be supported in using the watch and the associated Health Mate app and contacted two months into the study to assess understanding, compliance, and any adverse events. During the study, participants will complete event forms and transmit ECG recordings when symptomatic. Researchers will evaluate the rate at which the connected watch identifies arrhythmias compared to the Holter ECG, along with types of diagnoses and the time healthcare professionals spend per diagnosis. The primary outcome is measured at six months or when the watch is returned. The study includes follow-up calls and data collection on diagnosis rates and medical time to assess the cost-effectiveness of the connected watch strategy.
CONDITIONS
Brief Title
Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Any patient consulting primarily for palpitations without a previous arrhythmia diagnosis, or with different symptoms from a prior arrhythmia diagnosis
- Palpitations requiring cardiological consultation or emergency hospital treatment
- No suggestive diagnosis on intercritical 12-lead ECG (e.g., pre-excitation, high-grade atrioventricular block, atrial fibrillation with heart rate >110 bpm)
- Non-contributory stress test if symptoms occur during exercise
- Willing to wear the connected watch all the time except during charging
- Owns a personal smartphone or tablet compatible with the Health Mate app and internet connection
- Affiliated with a social security system
- Provides dated and signed informed consent form
You will not qualify if you...
- Refusal to wear the connected watch
- Refusal to use the study-provided watch due to personal connected watch use
- Unable to use the connected watch (lack of understanding of its use)
- No smartphone available
- Wearer of implantable cardiac device (pacemaker or defibrillator)
- Known and treated arrhythmia with identical symptoms
- Heart disease requiring implantable device for prevention
- Associated syncope
- Obvious non-cardiac cause for symptoms
- Pregnant or breastfeeding women
- Unable to complete study follow-up due to geographical, linguistic, social, or psychological reasons
- Participation in another interfering clinical study
- Patient under guardianship or deprived of liberty
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours for Holter ECG; connected watch monitoring for 6 months
Participants receive a connected watch and a 48-hour Holter ECG monitor to record ECG data when symptoms occur. They are instructed on device use and supported in setting up the Health Mate application.
1 visit for device setup (in-person) and a follow-up phone call at 2 months
Duration - Up to 6 months
Participants wear the connected watch for up to 6 months to capture symptomatic ECG recordings and are monitored for diagnostic outcomes and device compliance.
Participants record ECGs during symptoms; follow-up phone call at 2 months
Trial Site Locations
Total: 1 location
1
Hopitaux Nord-Ouest Villefranche Sur Saone
Gleizé, France, 69400
Actively Recruiting
Research Team
O
OLIVIER LE VAVASSEUR, MEDECINE
C
COLINE PERRIER, ARC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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