Arrhythmias, CardiacenHEARTNCT04884100
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
A study testing Validating and improving PPG-based algorithms in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter
- What is being tested?
- Validating and improving PPG-based algorithms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2021to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
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.
Read the 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.
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Atrioventricular Block, Nodal Tachycardia, Atrioventricular Tachycardia
- Being tested
- Validating and improving PPG-based algorithms
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Atrioventricular Block, Tachycardia, Ventricular, Ventricular Premature Complexes, Atrial Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validating and improving PPG-based algorithmsOther
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
| Study group | Role | What they receive |
|---|---|---|
| PPG recording | Other | arrhythmia recording using PPG monitor Receives: Other: Validating and improving PPG-based algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start15 Sep 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arrhythmias, CardiacStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Etienne Pruvot, Centre Hospitalier Universitaire Vaudois
- Investigators
- Etienne PRUVOT, Professor, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884100
- Sponsor's protocol ID
- 2021-00586
- Acronym
- enHEART
- Status last verified
- Aug 2023
- First submitted
- 7 May 2021
- Last updated
- 1 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jeanningros L, Le Bloa M, Teres C, Herrera Siklody C, Porretta AP, Pascale P, Luca A, Solana Munoz J, Domenichini G, Meister TA, Soria Maldonado R, Tanner H, Vesin JM, Thiran JP, Lemay M, Rexhaj E, Pruvot E, Braun F. The influence of cardiac arrhythmias on the detection of heartbeats in the photoplethysmogram: benchmarking open-source algorithms. Physiol Meas. 2024 Feb 14;45(2). doi: 10.1088/1361-6579/ad2216.
PubMed 38266291
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
- ClinicalTrials.gov ID
- NCT04884100
- Acronym / sponsor ID
- enHEART / 2021-00586
- Conditions
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Atrioventricular Block, Nodal Tachycardia, Atrioventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPG recording | Other | Other: Validating and improving PPG-based algorithmsarrhythmia recording using PPG monitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18-year-old,
- Able to speak/read/understand French,
- Informed consent signed, and
- at least one of the following cardiac arrhythmias:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validating and improving PPG-based algorithmsOur 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 | Other | PPG recording |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- Derived from this study: PubMed 38266291Jeanningros L, Le Bloa M, Teres C, Herrera Siklody C, Porretta AP, Pascale P, Luca A, Solana Munoz J, Domenichini G, Meister TA, Soria Maldonado R, Tanner H, Vesin JM, Thiran JP, Lemay M, Rexhaj E, Pruvot E, Braun F. The influence of cardiac arrhythmias on the detection of heartbeats in the photoplethysmogram: benchmarking open-source algorithms. Physiol Meas. 2024 Feb 14;45(2). doi: 10.1088/1361-6579/ad2216.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne PRUVOT, Professor principal investigator
Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Validating and improving PPG-based algorithms in people with Arrhythmias, Cardiac and Atrial Fibrillation, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884100, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.