RecruitingNot Applicable

AI-Optimized Single-Feature Recognition Model for Heart Failure

China50 participantsStarted 2026-07-16

Plain-language summary

This prospective, single-center and observational study aims to develop and validate the single-feature artificial intelligence algorithm based on data collected via the wearable ECG patches in patients with heart failure (HF). The main question: Does the algorithm, using synchronized ECG and accelerometer signals from the ECG patches, achieve accurate detection of heart sounds (S1, S2, and in some patients S3, S4) compared with the Eko CORE 500 digital stethoscope in patients with acute exacerbation of HF? It aims to answer: Participants with confirmed HF (NYHA classification II-IV) will first undergo a 2-minute session of simultaneous ECG patches and digital stethoscope recordings, followed by standard 12-lead ECG, and then the repeated ECG patches and 2-minute heart sound recording session. Data will be used for algorithm training and validation. The primary endpoint is the accuracy of heart sound detection via the Vivalink ECG patches compared with the Eko CORE 500 digital stethoscope.

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 years old; * Body mass index (BMI) \< 35 kg/m²; * Diagnosed with heart failure: according to "Chinese Guidelines for Diagnosis and Treatment of Heart Failure in 2024", "ESC Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure in 2021", and "AHA/ACC/HFSA Guidelines for Management of Heart Failure in 2022"; * NYHA classification II - IV; * Able to fully understand the purpose and process of the trial, and willing to sign the informed consent form. Exclusion Criteria: * Physical disabilities that prevent safe and thorough testing; * Open wounds on the chest or the skin is allergic to the patches; * Large amount of pericardial effusion, pericardial tamponade, pleural friction rub, pneumothorax, and a large amount of pleural effusion, which may affect data collection; * Patients with severe comorbidities or unstable conditions, which may interfere with data collection during the study period; * Other situations where the investigator believes the subject is not suitable to participate in this trial, such as those that may increase trial risk, affect the protocol compliance, or impair the subject's ability to complete the trial due to physical or psychological diseases or conditions.

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

Heart sounds include S1 and S2

Timeframe: 10-15 minutes

Trial details

NCT IDNCT07667452

SponsorVivalink

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-02-28

View on ClinicalTrials.gov More Cardiac Sound trials