AI-powered single-feature heart sound detector for heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, single-center study collects synchronized data from wearable ECG patches and a digital stethoscope to train and validate a small-feature AI that detects heart sounds. Participants with NYHA II–IV heart failure will undergo a 2-minute paired recording session, then standard ECG, followed by another 2-minute session to build a dataset for algorithm development. The primary outcome is how accurately the AI-identifies heart sounds from the wearable patch data compared with the Eko CORE 500 stethoscope. The study uses training and validation phases to assess performance in acute HF settings and may inform future remote monitoring approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.