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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation; Arrhythmias, Cardiac; Ventricular Tachycardia; Atrioventricular Block; Atrial Flutter; Premature Ventricular Contraction; Premature Atrial Complex; Nodal Tachycardia; Atrioventricular Tachycardia
• Intervention / Treatment: Other: Validating and improving PPG-based algorithms

Detailed Description

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:

1. Clinical data such as age, gender, weight, size, BMI, blood pressure and heart rate, cardiovascular risk factors, clinical history
2. Baseline treatment and treatment at time of the electrophysiological procedure
3. Arrhythmia type and arrhythmia-related symptoms
4. 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:

1. Surface ECG signals
2. 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
3. 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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: PPG recording; arrhythmia recording using PPG monitor

Other: Validating and improving PPG-based algorithms; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois
• Investigators: Principal Investigator: Etienne PRUVOT, Professor, Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Actual): July 21, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: May 7, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Heart Block; Cardiac Complexes, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Atrial Fibrillation; Premature Birth; Arrhythmias, Cardiac; Tachycardia; Tachycardia, Ventricular; Atrial Flutter; Atrioventricular Block; Ventricular Premature Complexes; Atrial Premature Complexes
• Other Study ID Numbers: 2021-00586

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No