Heart Failure Clinical Trials

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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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.

Locations
Other Locations
China
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Time Frame
Start Date: 2026-07-16
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Leads: Vivalink
Collaborators: Second Affiliated Hospital, Zhejiang University, School of Medicine

This content was sourced from clinicaltrials.gov