NCT04884100|Completed
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
enHEART
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enHEART
Sponsor study identifier
interventional
95
1 country
1
Study Start
September 15, 2021
Actual (reported)Primary Completion
July 21, 2023
Actual (reported)Study Completion
July 21, 2023
Actual (reported)This research will investigate the PPG signal morphology related to physiological and non- physiological changes in arrhythmia-related heart rate as well as the performance of the PPG-based features previously developed within the framework of the Mini-Holter study to discriminate between several cardiac arrhythmias. To this end, clinical data will be recorded on patients by using a wrist-based PPG monitor simultaneously with 12-lead ECG and intracardiac electrogram (EGM) signals at the university hospital in Lausanne. Importantly, this study will remain purely observational as it will not change the diagnostic and therapeutic management of the included patients, nor will it interfere with the time course of the procedures. The aim of enHEART study is to validate on a larger database the ability of several previously developed PPG-based features to detect a variety of cardiac arrhythmias.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 21, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 7, 2021
Actual (reported)May 12, 2021
Actual (reported)September 15, 2021
Actual (reported)July 21, 2023
Actual (reported)July 21, 2023
Actual (reported)Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.
Standard statistical quantities related to a classification task will be reported: accuracy, sensitivity, specificity, positive predictive value, F1 score and area under the receiver operating characteristics curve.
2 years
arrhythmia recording using PPG monitor
Our project aims at validating and improving PPG-based algorithms that were previously developed during the time course of a preceding study mini-Holter, accepted by the CER-VD in 2015. The developed features might help improve our understanding of the physio-pathological expression of cardiac arrhythmias. Indeed, current evidence demonstrates that PPG signals contain rich information on diverse cardiovascular mechanisms and properties
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011, Switzerland
Jeanningros L, Le Bloa M, Teres C, Herrera Siklody C, Porretta AP, Pascale P, Luca A, Solana Munoz J, Domenichini G, Meister TA, Soria Maldonado R, Tanner H, Vesin JM, Thiran JP, Lemay M, Rexhaj E, Pruvot E, Braun F. The influence of cardiac arrhythmias on the detection of heartbeats in the photoplethysmogram: benchmarking open-source algorithms. Physiol Meas. 2024 Feb 14;45(2). doi: 10.1088/1361-6579/ad2216.
Etienne PRUVOT, Professor
Centre Hospitalier Universitaire Vaudois
95 participants (actual enrollment reported by the registry).
First Submitted
May 7, 2021
First Posted
May 12, 2021
Study Start
September 15, 2021
Actual (reported)Diagnostic Accuracy of WEARable TECHnology Single-lead ECG in Detecting Cardiac Arrhythmias
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Primary Completion
July 21, 2023
Actual (reported)Study Completion
July 21, 2023
Actual (reported)Last Updated
September 1, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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