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

NCT04884100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 95

Last updated 2023-09-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire Vaudois

    lead OTHER

Principal Investigators

  • Etienne PRUVOT, Professor · Centre Hospitalier Universitaire Vaudois

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2023-07-21
Completion
2023-07-21

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884100 on ClinicalTrials.gov