Analysis of optical signals to improve the screening of cardiac arrhythmias
Résumé de l'étude
The objective is to develop a computer program that allows for a presumptive diagnosis of the type of arrhythmia the patient suffers from. Such a means is currently lacking. Indeed, although smartwatches offer the possibility of cardiac monitoring (using a photoplethysmography signal, PPG), no presumptive diagnosis can currently be established. If the study is successful, the results would allow for better prediction of the type of arrhythmia for a given patient, thus limiting the need to consult specialists and/or possibly reducing the need for sometimes complex additional examinations.
(BASEC)
Intervention étudiée
Recording the electrical signals of the heart by measuring a photoplethysmography (PPG) signal during an investigation or treatment of cardiac rhythm disorders.
(BASEC)
Maladie en cours d'investigation
Cardiac rhythm disorders
(BASEC)
- Age: >18 years - At least one of the following cardiac arrhythmias: sustained or nonsustained ventricular tachycardia, sustained or nonsustained atrial tachycardia, atrial flutter, frequent atrial and/or ventricular ectopic beats, atrial and/or ventricular bigeminy, left bundle branch block, second or third degree atrioventricular block, reentrant atrioventricular tachycardia or reentrant nodal atrioventricular tachycardia, atrial fibrillation - Signed consent (BASEC)
Critères d'exclusion
- Patient refusal to participate in the study - Patient unable to discern or under guardianship - Patient already included in another study (ClinO/HRO) that could affect the objectives of this study (BASEC)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Etienne Pruvot
+41 21 314 00 12
etienne.pruvot@clutterchuv.chCHUV
(BASEC)
Informations générales
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
25.05.2021
(BASEC)
Identifiant de l'essai ICTRP
NCT04884100 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
EnHeart : exploring full content of optical signals to enhance cardiac arrhythmia screening (BASEC)
Titre académique
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Titre public
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Maladie en cours d'investigation
Premature Atrial Complex
Premature Ventricular Contraction
Atrial Flutter
Nodal Tachycardia
Arrhythmias, Cardiac
Atrial Fibrillation
Atrioventricular Block
Atrioventricular Tachycardia
Ventricular Tachycardia
(ICTRP)
Intervention étudiée
Other: Validating and improving PPG-based algorithms
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Inclusion Criteria:
1. Age = 18-year-old,
2. Able to speak/read/understand French,
3. Informed consent signed, and
4. at least one of the following cardiac arrhythmias:
- sustained or non-sustained ventricular tachycardia,
- sustained or non-sustained atrial tachycardia
- atrial flutter,
- frequent atrial and/or ventricular ectopic beats,
- ventricular and/or atrial bigeminy,
- left bundle branch block,
- second- or third-degree atrioventricular block,
- atrioventricular reentrant tachycardia or atrioventricular node reentrant
tachycardia,
- AF
Exclusion Criteria:
1. Patient is pregnant or breastfeeding,
2. Refusal of participation by the patient
3. Patient is less than 18 years old,
4. Patient incapable of judgement or under tutelage, or
5. Patient is already included in another human research project (ClinO/HRO) that may
affect the objectives of this study.
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.
(ICTRP)
non disponible
Date d'enregistrement
07.05.2021 (ICTRP)
Inclusion du premier participant
15.09.2021 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Etienne PRUVOT, Professor, Centre Hospitalier Universitaire Vaudois (ICTRP)
ID secondaires
2021-00586 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04884100 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible