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

Primary Purpose

Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Validating and improving PPG-based algorithms
Sponsored by
Centre Hospitalier Universitaire Vaudois
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Arrhythmias, Cardiac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PPG recording

Arm Description

arrhythmia recording using PPG monitor

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2021
Last Updated
August 31, 2023
Sponsor
Centre Hospitalier Universitaire Vaudois
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1. Study Identification

Unique Protocol Identification Number
NCT04884100
Brief Title
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
Acronym
enHEART
Official Title
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
July 21, 2023 (Actual)
Study Completion Date
July 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Hospitalier Universitaire Vaudois

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Atrioventricular Block, Nodal Tachycardia, Atrioventricular Tachycardia, Ventricular Tachycardia, Premature Ventricular Contraction, Premature Atrial Complex

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PPG recording
Arm Type
Other
Arm Description
arrhythmia recording using PPG monitor
Intervention Type
Other
Intervention Name(s)
Validating and improving PPG-based algorithms
Intervention Description
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 Outcome Measure Information:
Title
Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.
Description
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.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne PRUVOT, Professor
Organizational Affiliation
Centre Hospitalier Universitaire Vaudois
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

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

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