Analysis of optical signals to improve the screening of cardiac arrhythmias
Summary description of the study
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 under investigation
Recording the electrical signals of the heart by measuring a photoplethysmography (PPG) signal during an investigation or treatment of cardiac rhythm disorders.
(BASEC)
Disease under 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)
Exclusion criteria
- 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)
Trial sites
Lausanne
(BASEC)
Sponsor
CHUV
(BASEC)
Contact
Contact Person Switzerland
Prof. Etienne Pruvot
+41 21 314 00 12
etienne.pruvot@clutterchuv.chCHUV
(BASEC)
General Information
Centre Hospitalier Universitaire Vaudois
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
25.05.2021
(BASEC)
ICTRP Trial ID
NCT04884100 (ICTRP)
Official title (approved by ethics committee)
EnHeart : exploring full content of optical signals to enhance cardiac arrhythmia screening (BASEC)
Academic title
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Public title
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (ICTRP)
Disease under investigation
Premature Atrial Complex
Premature Ventricular Contraction
Atrial Flutter
Nodal Tachycardia
Arrhythmias, Cardiac
Atrial Fibrillation
Atrioventricular Block
Atrioventricular Tachycardia
Ventricular Tachycardia
(ICTRP)
Intervention under investigation
Other: Validating and improving PPG-based algorithms
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.
(ICTRP)
not available
Registration date
07.05.2021 (ICTRP)
Incorporation of the first participant
15.09.2021 (ICTRP)
Secondary sponsors
not available
Additional contacts
Etienne PRUVOT, Professor, Centre Hospitalier Universitaire Vaudois (ICTRP)
Secondary trial IDs
2021-00586 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04884100 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available