Analysis of optical signals to improve the screening of cardiac arrhythmias
Descrizione riassuntiva dello studio
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)
Intervento studiato
Recording the electrical signals of the heart by measuring a photoplethysmography (PPG) signal during an investigation or treatment of cardiac rhythm disorders.
(BASEC)
Malattie studiate
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)
Criteri di esclusione
- 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)
Luogo dello studio
Losanna
(BASEC)
Sponsor
CHUV
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Etienne Pruvot
+41 21 314 00 12
etienne.pruvot@clutterchuv.chCHUV
(BASEC)
Informazioni generali
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
25.05.2021
(BASEC)
ID di studio ICTRP
NCT04884100 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
EnHeart : exploring full content of optical signals to enhance cardiac arrhythmia screening (BASEC)
Titolo accademico
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Titolo pubblico
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Malattie studiate
Premature Atrial Complex
Premature Ventricular Contraction
Atrial Flutter
Nodal Tachycardia
Arrhythmias, Cardiac
Atrial Fibrillation
Atrioventricular Block
Atrioventricular Tachycardia
Ventricular Tachycardia
(ICTRP)
Intervento studiato
Other: Validating and improving PPG-based algorithms
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.
(ICTRP)
non disponibile
Data di registrazione
07.05.2021 (ICTRP)
Inclusione del primo partecipante
15.09.2021 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Etienne PRUVOT, Professor, Centre Hospitalier Universitaire Vaudois (ICTRP)
ID secondari
2021-00586 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04884100 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile