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

NCT04884100 | Completed

• 1 other identifier: 2021-00586
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Atrioventricular Block; Nodal Tachycardia; Atrioventricular Tachycardia; Ventricular Tachycardia; Premature Ventricular Contraction; Premature Atrial Complex

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PPG recording

OTHER

arrhythmia recording using PPG monitor

Other: Validating and improving PPG-based algorithms

Interventions

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

PPG recording

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation; Atrial Flutter; Atrioventricular Block; Tachycardia, Ventricular; Ventricular Premature Complexes; Atrial Premature Complexes

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Block; Cardiac Conduction System Disease; Tachycardia; Cardiac Complexes, Premature

Study Officials

• Etienne PRUVOT, Professor

  Centre Hospitalier Universitaire Vaudois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: September 15, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Locations

CH (1)