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ID06420960

Comparing Diagnostic Effectiveness of Connected Watch ECG and 48-Hour External Holter ECG for Detecting Palpitations Without ECG 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

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

Research Team

O

OLIVIER LE VAVASSEUR, MEDECINE

C

COLINE PERRIER, ARC

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