enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening

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.

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Key information

Conditions

Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Atrial Premature Complexes Atrioventricular Block Atrioventricular Tachycardia Cardiac Complexes, Premature Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Nodal Tachycardia Pathologic Processes Pathological Conditions, Signs and Symptoms Premature Atrial Complex Premature Ventricular Contraction Tachycardia Tachycardia, Ventricular Ventricular Premature Complexes Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

The aim of the study is to acquire high quality PPG signals of various types of cardiac arrhythmias during diagnostic and therapeutic procedures, under controlled conditions (i.e., electrophysiology lab), which can be compared beat-to-beat to a concurrently-acquired, gold-standard reference (12-lead ECG and intracardiac EGM signals), and expert annotations by CHUV physicians. To this end, a total of 99 patients referred for diagnostic or therapeutic interventions (ablation) of 9 different types of cardiac arrhythmias at the CHUV will be enrolled. 11 patients per type of arrhythmia will be included.

The following clinical data will be collected from the electronic file of the patient:

Clinical data such as age, gender, weight, size, BMI, blood pressure and heart rate, cardiovascular risk factors, clinical history
Baseline treatment and treatment at time of the electrophysiological procedure
Arrhythmia type and arrhythmia-related symptoms
Left and right ventricular ejection fraction as provided by the patient's private cardiologist echocardiogram.

The following paraclinical data will be synchronously collected during the diagnostic and/or therapeutic intervention in the electrophysiology laboratory:

Surface ECG signals
Intracardiac EGM signals as provided by the intracardiac catheters used for the diagnostic and/or therapeutic interventions. Depending on the type of intervention, up to three different catheters may be used
PPG signals as provided by the PPG wrist monitor

The primary objective of our study is to investigate if features extracted from the pulse morphology of PPG signals (waveform-based features) significantly improve the classification accuracy of cardiac arrhythmias compared to a classification based on heart rate variation (HRV) features only.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18-year-old,
Able to speak/read/understand French,
Informed consent signed, and
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

Patient is pregnant or breastfeeding,
Refusal of participation by the patient
Patient is less than 18 years old,
Patient incapable of judgement or under tutelage, or
Patient is already included in another human research project (ClinO/HRO) that may affect the objectives of this study.

Treatment and study plan

Validating and improving PPG-based algorithms

Other

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

Primary outcomes

Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.

Time frame: 2 years

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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Acronym: enHEART

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: May 12, 2021
Registry last updated: Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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