Cardiovascular DiseasesNCT07825246
Development and Clinical Validation of a Smart Analysis System for a Wearable Cardiac Ultrasound Device
A study testing Wearable Cardiac Ultrasound System in people with Cardiovascular Diseases, run by Kunjing Pang.
Trial summary
The goal of this observational study is to learn if a wearable heart ultrasound system with automated analysis works as well as standard bedside ultrasound for continuous heart function monitoring in adults and children with severe heart conditions in intensive care units (ICUs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Wearable Cardiac Ultrasound System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2026to 16 Mar 2029
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adult patients with perioperative cardiopulmonary critical illness admitted to the adult ICU or CCU at Fuwai Hospital, including patients with coronary artery disease or valvular heart disease after cardiac surgery, and patients undergoing interventional procedures for structural heart disease.
- Pediatric patients with perioperative cardiopulmonary critical illness admitted to the pediatric intensive care unit (PICU) at Fuwai Hospital, including patients with congenital heart disease after cardiac surgery.
Who cannot join
- Severe wound infection or delayed thoracic closure that prevents placement of the wearable cardiac ultrasound monitoring device.
- Patient or family refusal to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this observational study is to learn if a wearable heart ultrasound system with automated analysis works as well as standard bedside ultrasound for continuous heart function monitoring in adults and children with severe heart conditions in intensive care units (ICUs). The study will also test if the system can help guide minimally invasive procedures for structural heart defects. About 610 people will take part in this research.
The main questions it aims to answer are:
Read more
- Do heart function measurements from the wearable ultrasound system match results from standard bedside ultrasound exams?
- How accurately can the automated analysis tool measure heart function using images from the wearable device?
- Is it feasible and safe to use the wearable ultrasound system to help guide minimally invasive closure of heart defects?
Researchers will compare readings collected by the wearable ultrasound device to results from standard bedside ultrasound exams. They will check how closely the two methods agree to see if the wearable system can replace standard testing for ongoing heart monitoring. The research team will remove all personal identifiers from all study data to protect each participant's privacy.
Participants will:
- Wear a small, soft ultrasound patch on their chest to continuously monitor their heart structure and function
- Receive standard bedside ultrasound exams as part of their routine intensive care
- Allow the research team to collect their heart images and vital signs (heart rate, blood pressure, and oxygen levels) for study analysis
- If they receive a minimally invasive procedure to fix a heart defect, the research team will use the wearable ultrasound device during the procedure to help guide treatment
- Conditions
- Cardiovascular Diseases
- Being tested
- Wearable Cardiac Ultrasound System
- Keywords
- Wearable ultrasound, Echocardiography, Artificial intelligence, Cardiac function monitoring, Structural heart disease
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Cardiac Ultrasound SystemDevice
A soft, wearable ultrasound patch is applied to the participant's chest to continuously acquire cardiac ultrasound images. The system performs real-time 2D echocardiographic imaging, Doppler assessment, and automated cardiac function measurement. Ultrasound data is transmitted wirelessly for remote review by experienced sonographers, and synchronized with bedside vital sign monitors. Study staff compare measurements from the wearable system with results from standard bedside echocardiography to evaluate consistency and accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Cardiac Ultrasound Monitoring | Experimental | Participants will undergo continuous cardiac structure and function monitoring with the wearable cardiac ultrasound system. They will also receive standard bedside echocardiography as routine clinical care. The study team will compare measurements from the wearable device with results from standard echocardiography to evaluate the accuracy and consistency of the wearable system. Receives: Device: Wearable Cardiac Ultrasound System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Difference in LVEF Measurements Between Wearable Cardiac Ultrasound and Standard Bedside Echocardiography
LVEF (%) measured from wearable cardiac ultrasound images will be compared with LVEF (%) measured by an experienced echocardiographer using standard bedside echocardiography. The primary outcome is the mean difference in LVEF between the two methods, calculated as wearable cardiac ultrasound minus standard bedside echocardiography. The mean difference and its 95% confidence interval will be calculated. Bland-Altman analysis will also be performed to estimate the 95% limits of agreement between the two methods.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion5 Sep 2028 (estimated)
- Study completion16 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kunjing Pang
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Kunjing Pang, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825246
- Sponsor's protocol ID
- 2026-ZX041
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy and confidentiality of study participants. The dataset contains sensitive clinical medical records and identifiable cardiac imaging data of critically ill patients, which are governed by institutional data security policies and ethical review requirements. No external data sharing plan is designated for this study.
Publications
Zou F, Luo Y, Zhuang W, Xu T. A Fully Integrated Conformal Wearable Ultrasound Patch for Continuous Sonodynamic Therapy. Adv Mater. 2024 Sep;36(39):e2409528. doi: 10.1002/adma.202409528. Epub 2024 Aug 6.
PubMed 39104292Chu Y, Li C, Zhang W, et al. Human pulse diagnosis for medical assessments using a wearable piezoelectret sensing system. Adv Funct Mater. 2018 Oct;28(40):1803413.
Zhang L, Yu K, Wang Y, et al. A conformable phased-array ultrasound patch for bladder volume monitoring. Nat Electron. 2024 Jan;7(1):77-90.
Du W, Zhang L, Suh E, Lin D, Marcus C, Ozkan L, Ahuja A, Fernandez S, Shuvo II, Sadat D, Liu W, Li F, Chandrakasan AP, Ozmen T, Dagdeviren C. Conformable ultrasound breast patch for deep tissue scanning and imaging. Sci Adv. 2023 Jul 28;9(30):eadh5325. doi: 10.1126/sciadv.adh5325. Epub 2023 Jul 28.
PubMed 37506210Liu HC, Zeng Y, Gong C, Chen X, Kijanka P, Zhang J, Genyk Y, Tchelepi H, Wang C, Zhou Q, Zhao X. Wearable bioadhesive ultrasound shear wave elastography. Sci Adv. 2024 Feb 9;10(6):eadk8426. doi: 10.1126/sciadv.adk8426. Epub 2024 Feb 9.
PubMed 38335289Wang C, Chen X, Wang L, Makihata M, Liu HC, Zhou T, Zhao X. Bioadhesive ultrasound for long-term continuous imaging of diverse organs. Science. 2022 Jul 29;377(6605):517-523. doi: 10.1126/science.abo2542. Epub 2022 Jul 28.
PubMed 35901155Min S, An J, Lee JH, Kim JH, Joe DJ, Eom SH, Yoo CD, Ahn HS, Hwang JY, Xu S, Rogers JA, Lee KJ. Wearable blood pressure sensors for cardiovascular monitoring and machine learning algorithms for blood pressure estimation. Nat Rev Cardiol. 2025 Sep;22(9):629-648. doi: 10.1038/s41569-025-01127-0. Epub 2025 Feb 18.
PubMed 39966649Hu H, Huang H, Li M, Gao X, Yin L, Qi R, Wu RS, Chen X, Ma Y, Shi K, Li C, Maus TM, Huang B, Lu C, Lin M, Zhou S, Lou Z, Gu Y, Chen Y, Lei Y, Wang X, Wang R, Yue W, Yang X, Bian Y, Mu J, Park G, Xiang S, Cai S, Corey PW, Wang J, Xu S. A wearable cardiac ultrasound imager. Nature. 2023 Jan;613(7945):667-675. doi: 10.1038/s41586-022-05498-z. Epub 2023 Jan 25.
PubMed 36697864Sempionatto JR, Lin M, Yin L, De la Paz E, Pei K, Sonsa-Ard T, de Loyola Silva AN, Khorshed AA, Zhang F, Tostado N, Xu S, Wang J. An epidermal patch for the simultaneous monitoring of haemodynamic and metabolic biomarkers. Nat Biomed Eng. 2021 Jul;5(7):737-748. doi: 10.1038/s41551-021-00685-1. Epub 2021 Feb 15.
PubMed 33589782Wang C, Li X, Hu H, Zhang L, Huang Z, Lin M, Zhang Z, Yin Z, Huang B, Gong H, Bhaskaran S, Gu Y, Makihata M, Guo Y, Lei Y, Chen Y, Wang C, Li Y, Zhang T, Chen Z, Pisano AP, Zhang L, Zhou Q, Xu S. Monitoring of the central blood pressure waveform via a conformal ultrasonic device. Nat Biomed Eng. 2018 Sep;2(9):687-695. doi: 10.1038/s41551-018-0287-x. Epub 2018 Sep 11.
PubMed 30906648
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Validation of a Smart Analysis System for a Wearable Cardiac Ultrasound Device
- ClinicalTrials.gov ID
- NCT07825246
- Acronym / sponsor ID
- 2026-ZX041
- Conditions
- Cardiovascular Diseases
- Keywords
- Wearable ultrasound, Echocardiography, Artificial intelligence, Cardiac function monitoring, Structural heart disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Kunjing PangOther government
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 5 Sep 2028 (estimated)
- Study completion
- 16 Mar 2029 (estimated)
- First posted
- 17 Sep 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.
The goal of this observational study is to learn if a wearable heart ultrasound system with automated analysis works as well as standard bedside ultrasound for continuous heart function monitoring in adults and children with severe heart conditions in intensive care units (ICUs). The study will also test if the system can help guide minimally invasive procedures for structural heart defects. About 610 people will take part in this research.
The main questions it aims to answer are:
- Do heart function measurements from the wearable ultrasound system match results from standard bedside ultrasound exams?
- How accurately can the automated analysis tool measure heart function using images from the wearable device?
- Is it feasible and safe to use the wearable ultrasound system to help guide minimally invasive closure of heart defects?
Researchers will compare readings collected by the wearable ultrasound device to results from standard bedside ultrasound exams. They will check how closely the two methods agree to see if the wearable system can replace standard testing for ongoing heart monitoring. The research team will remove all personal identifiers from all study data to protect each participant's privacy.
Participants will:
- Wear a small, soft ultrasound patch on their chest to continuously monitor their heart structure and function
- Receive standard bedside ultrasound exams as part of their routine intensive care
- Allow the research team to collect their heart images and vital signs (heart rate, blood pressure, and oxygen levels) for study analysis
- If they receive a minimally invasive procedure to fix a heart defect, the research team will use the wearable ultrasound device during the procedure to help guide treatment
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable Cardiac Ultrasound Monitoring | Experimental | Device: Wearable Cardiac Ultrasound SystemParticipants will undergo continuous cardiac structure and function monitoring with the wearable cardiac ultrasound system. They will also receive standard bedside echocardiography as routine clinical care. The study team will compare measurements from the wearable device with results from standard echocardiography to evaluate the accuracy and consistency of the wearable system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with perioperative cardiopulmonary critical illness admitted to the adult ICU or CCU at Fuwai Hospital, including patients with coronary artery disease or valvular heart disease after cardiac surgery, and patients undergoing interventional procedures for structural heart disease.
- Pediatric patients with perioperative cardiopulmonary critical illness admitted to the pediatric intensive care unit (PICU) at Fuwai Hospital, including patients with congenital heart disease after cardiac surgery.
Key exclusion criteria (2 listed)
- Severe wound infection or delayed thoracic closure that prevents placement of the wearable cardiac ultrasound monitoring device.
- Patient or family refusal to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Cardiac Ultrasound SystemA soft, wearable ultrasound patch is applied to the participant's chest to continuously acquire cardiac ultrasound images. The system performs real-time 2D echocardiographic imaging, Doppler assessment, and automated cardiac function measurement. Ultrasound data is transmitted wirelessly for remote review by experienced sonographers, and synchronized with bedside vital sign monitors. Study staff compare measurements from the wearable system with results from standard bedside echocardiography to evaluate consistency and accuracy. | Device | Wearable Cardiac Ultrasound Monitoring |
Primary outcome
Mean Difference in LVEF Measurements Between Wearable Cardiac Ultrasound and Standard Bedside Echocardiography
Time frame: Day 1
LVEF (%) measured from wearable cardiac ultrasound images will be compared with LVEF (%) measured by an experienced echocardiographer using standard bedside echocardiography. The primary outcome is the mean difference in LVEF between the two methods, calculated as wearable cardiac ultrasound minus standard bedside echocardiography. The mean difference and its 95% confidence interval will be calculated. Bland-Altman analysis will also be performed to estimate the 95% limits of agreement between the two methods.
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 17 Sep 2026.
- Results publication: PubMed 39104292Zou F, Luo Y, Zhuang W, Xu T. A Fully Integrated Conformal Wearable Ultrasound Patch for Continuous Sonodynamic Therapy. Adv Mater. 2024 Sep;36(39):e2409528. doi: 10.1002/adma.202409528. Epub 2024 Aug 6.
- Results publicationChu Y, Li C, Zhang W, et al. Human pulse diagnosis for medical assessments using a wearable piezoelectret sensing system. Adv Funct Mater. 2018 Oct;28(40):1803413.
- Results publicationZhang L, Yu K, Wang Y, et al. A conformable phased-array ultrasound patch for bladder volume monitoring. Nat Electron. 2024 Jan;7(1):77-90.
- Results publication: PubMed 37506210Du W, Zhang L, Suh E, Lin D, Marcus C, Ozkan L, Ahuja A, Fernandez S, Shuvo II, Sadat D, Liu W, Li F, Chandrakasan AP, Ozmen T, Dagdeviren C. Conformable ultrasound breast patch for deep tissue scanning and imaging. Sci Adv. 2023 Jul 28;9(30):eadh5325. doi: 10.1126/sciadv.adh5325. Epub 2023 Jul 28.
- Results publication: PubMed 38335289Liu HC, Zeng Y, Gong C, Chen X, Kijanka P, Zhang J, Genyk Y, Tchelepi H, Wang C, Zhou Q, Zhao X. Wearable bioadhesive ultrasound shear wave elastography. Sci Adv. 2024 Feb 9;10(6):eadk8426. doi: 10.1126/sciadv.adk8426. Epub 2024 Feb 9.
- Results publication: PubMed 35901155Wang C, Chen X, Wang L, Makihata M, Liu HC, Zhou T, Zhao X. Bioadhesive ultrasound for long-term continuous imaging of diverse organs. Science. 2022 Jul 29;377(6605):517-523. doi: 10.1126/science.abo2542. Epub 2022 Jul 28.
- Results publication: PubMed 39966649Min S, An J, Lee JH, Kim JH, Joe DJ, Eom SH, Yoo CD, Ahn HS, Hwang JY, Xu S, Rogers JA, Lee KJ. Wearable blood pressure sensors for cardiovascular monitoring and machine learning algorithms for blood pressure estimation. Nat Rev Cardiol. 2025 Sep;22(9):629-648. doi: 10.1038/s41569-025-01127-0. Epub 2025 Feb 18.
- Results publication: PubMed 36697864Hu H, Huang H, Li M, Gao X, Yin L, Qi R, Wu RS, Chen X, Ma Y, Shi K, Li C, Maus TM, Huang B, Lu C, Lin M, Zhou S, Lou Z, Gu Y, Chen Y, Lei Y, Wang X, Wang R, Yue W, Yang X, Bian Y, Mu J, Park G, Xiang S, Cai S, Corey PW, Wang J, Xu S. A wearable cardiac ultrasound imager. Nature. 2023 Jan;613(7945):667-675. doi: 10.1038/s41586-022-05498-z. Epub 2023 Jan 25.
- Results publication: PubMed 33589782Sempionatto JR, Lin M, Yin L, De la Paz E, Pei K, Sonsa-Ard T, de Loyola Silva AN, Khorshed AA, Zhang F, Tostado N, Xu S, Wang J. An epidermal patch for the simultaneous monitoring of haemodynamic and metabolic biomarkers. Nat Biomed Eng. 2021 Jul;5(7):737-748. doi: 10.1038/s41551-021-00685-1. Epub 2021 Feb 15.
- Results publication: PubMed 30906648Wang C, Li X, Hu H, Zhang L, Huang Z, Lin M, Zhang Z, Yin Z, Huang B, Gong H, Bhaskaran S, Gu Y, Makihata M, Guo Y, Lei Y, Chen Y, Wang C, Li Y, Zhang T, Chen Z, Pisano AP, Zhang L, Zhou Q, Xu S. Monitoring of the central blood pressure waveform via a conformal ultrasonic device. Nat Biomed Eng. 2018 Sep;2(9):687-695. doi: 10.1038/s41551-018-0287-x. Epub 2018 Sep 11.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy and confidentiality of study participants. The dataset contains sensitive clinical medical records and identifiable cardiac imaging data of critically ill patients, which are governed by institutional data security policies and ethical review requirements. No external data sharing plan is designated for this study.
Related trials for Cardiovascular Diseases
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 1/2
A Phase 1b/2 Study of Sonrotoclax (BGB-11417) as Monotherapy and in Various Combinations With Dexamethasone Plus Carfilzomib, Dexamethasone Plus Daratumumab, and Dexamethasone Plus Pomalidomide in Multiple Myeloma
Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2
Testing the Combination of Venetoclax and Rituximab, in Comparison to the Usual Treatment (Ibrutinib Plus Rituximab or Zanubrutinib Alone) for Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma
Lymphoplasmacytic Lymphoma, Waldenstrom Macroglobulinemia
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.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Cardiac Ultrasound System in people with Cardiovascular Diseases, run by Kunjing Pang.
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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Kunjing Pang (13520114557, pangkunjing2020@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in LVEF Measurements Between Wearable Cardiac Ultrasound and Standard Bedside Echocardiography (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07825246, which also lists 10 linked publications.
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 17 Sep 2026.