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AI-Powered patch listens for heart failure clues

NCT ID NCT07667452

Knowledge-focused Sponsor: Vivalink Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 4 times

Summary

This observational study will test whether an artificial intelligence algorithm can accurately detect heart sounds using data from a wearable ECG patch in 50 people with heart failure. Participants will wear the patch and have their heart sounds recorded with a digital stethoscope for comparison. The goal is to develop a simple, non-invasive tool that could help monitor heart failure more effectively.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple, wearable device that helps doctors monitor heart failure patients more easily and catch problems earlier.
What could go wrong
This is a small, early-stage observational study, not a treatment trial. The AI algorithm may not work as well in real-world settings or in different patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients diagnosed with heart failure (NYHA classification II\~IV)

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiac sound Heart failure - nyha ii - iv

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, China

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