Diagnostic Efficacy of Connected WAtch ECG Versus External Holter ECG
Launched by L'HÔPITAL NORD-OUEST - VILLEFRANCHE VILLEFRANCHE SUR SAÔNE · May 15, 2024
Trial Information
Current as of February 19, 2025
Not yet recruiting
Keywords
ClinConnect Summary
No description provided
Gender
ALL
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.
About L'hôpital Nord Ouest Villefranche Villefranche Sur Saône
L'Hôpital Nord-Ouest, located in Villefranche-sur-Saône, is a leading healthcare institution dedicated to advancing medical research and improving patient care. As a clinical trial sponsor, the hospital is committed to conducting high-quality, ethically responsible research that adheres to rigorous regulatory standards. With a multidisciplinary team of experts and state-of-the-art facilities, L'Hôpital Nord-Ouest aims to contribute to innovative therapeutic solutions and enhance clinical outcomes across various medical specialties. The institution fosters collaboration with academic partners and the pharmaceutical industry, ensuring that patient safety and scientific integrity remain at the forefront of its clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Gleize, , France
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Discussion 0