AI-Optimized Single-Feature Recognition Model for Heart Failure

July 18, 2026 updated by: Vivalink

Development and Application of a Single-Feature Recognition Model for Heart Failure With Artificial Intelligence-Optimized Algorithms

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Principal Investigator:
          • Xiaojie Xie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart sounds include S1 and S2
Time Frame: 10-15 minutes
In some patients, S3 and S4 are also present.
10-15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vivalink

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

June 15, 2026

First Submitted That Met QC Criteria

June 23, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 18, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 20260571

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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