enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening (NCT04884100) | Clinical Trial Compass
CompletedNot Applicable
enHEART - Exploring Full Content of Optical Signals to Enhance Cardiac Arrhythmia Screening
Switzerland95 participantsStarted 2021-09-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18-year-old,
. Able to speak/read/understand French,
. Informed consent signed, and
. at least one of the following cardiac arrhythmias:
Exclusion criteria
. Patient is pregnant or breastfeeding,
. Refusal of participation by the patient
. Patient is less than 18 years old,
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Performances of cardiac arrhythmias classification based on Photoplethysmography (PPG) signals.