Development and Clinical Validation of a Smart Analysis System for a Wearable Cardiac Ultrasound Device

September 16, 2026 updated by: Kunjing Pang

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Wearable Cardiac Ultrasound Monitoring
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.
Device: Wearable Cardiac Ultrasound System
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kunjing Pang

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 16, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026-ZX041

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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