Cardiac SoundNCT07667452
AI-Optimized Single-Feature Recognition Model for Heart Failure
An observational study of Cardiac Sound and Heart Failure - NYHA II - IV, run by Vivalink at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Sound, Heart Failure - NYHA II - IV
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Adult patients diagnosed with heart failure (NYHA classification II~IV)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang
Bing Yang, +86 13395719536, yangbing@vivalink.com.cn
Xiaojie Xie
About this study
Official title: 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.
- Conditions
- Cardiac Sound, Heart Failure - NYHA II - IV
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart sounds include S1 and S2
In some patients, S3 and S4 are also present.
Measured: 10-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start16 Jul 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vivalink
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667452
- Sponsor's protocol ID
- 20260571
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application of a Single-Feature Recognition Model for Heart Failure With Artificial Intelligence-Optimized Algorithms
- ClinicalTrials.gov ID
- NCT07667452
- Acronym / sponsor ID
- 20260571
- Conditions
- Cardiac Sound, Heart Failure - NYHA II - IV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VivalinkIndustry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with heart failure (NYHA classification II~IV)
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart sounds include S1 and S2
Time frame: 10-15 minutes
In some patients, S3 and S4 are also present.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Sound and Heart Failure - NYHA II - IV, run by Vivalink at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart sounds include S1 and S2 (time frame: 10-15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.