An interventional study of Wearable Ultrasound Imaging System in Cardiovascular Diseases, sponsored by China National Center for Cardiovascular Diseases. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by China National Center for Cardiovascular Diseases · Not applicable, Interventional, and Diagnostic
This study aims to evaluate the accuracy, feasibility, and clinical usefulness of a wearable ultrasound imaging system for cardiac monitoring during perioperative care and in intensive care units (ICUs).
Traditional bedside echocardiography provides important information about heart structure and function but is usually performed intermittently. Wearable ultrasound technology may allow more frequent monitoring of cardiac function and help healthcare professionals recognize changes in patients' conditions.
This prospective device-comparison study plans to enroll 600 patients, including 400 adults and 200 children, receiving care in cardiac intensive care settings at Fuwai Hospital.
Participants will undergo cardiac monitoring using a wearable ultrasound imaging system in addition to conventional bedside echocardiography. The wearable device will obtain cardiac ultrasound images that can be transmitted wirelessly for remote assessment by physicians. Under stable clinical conditions, ultrasound assessments will generally be performed hourly, with additional assessments when significant circulatory changes occur. Conventional bedside echocardiography will be performed daily for comparison.
The study will compare measurements of cardiac structure and function obtained using the two methods, including left ventricular ejection fraction (LVEF), and evaluate their agreement and ability to identify clinically important cardiovascular changes.
In a subgroup of 400 participants (300 adults and 100 children), wearable ultrasound images will also be displayed alongside electrocardiography, blood pressure, and oxygen saturation measurements on bedside monitors to evaluate the feasibility and potential clinical benefits of integrated monitoring.
The findings may help determine whether wearable ultrasound technology can provide accurate and practical cardiac monitoring for critically ill patients.
5,025 studies on the registry are indexed under Cardiovascular Diseases; 930 are open to participants now.
This study's planned enrollment of 600 is above the median of 100 across 2,801 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →China National Center for Cardiovascular Diseases is the lead sponsor of 262 studies on the registry; 138 are open to participants now.
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Exclusion Criteria:
All participants will undergo cardiac monitoring using a wearable ultrasound imaging system in addition to conventional bedside echocardiography. Wearable ultrasound assessments will generally be performed hourly under stable clinical conditions and additionally when significant circulatory changes occur. Conventional bedside echocardiography will be performed daily for comparison. A subgroup of 400 participants will also undergo integrated monitoring combining wearable ultrasound with electrocardiography, blood pressure, and oxygen saturation measurements.
Device: Wearable Ultrasound Imaging System
A wearable ultrasound transducer will be positioned on the chest by an experienced sonographer to obtain cardiac images, primarily the apical four-chamber view. Images will be transmitted wirelessly for remote review. Two-dimensional, color Doppler, spectral Doppler, and M-mode imaging will be used to assess cardiac structure and function, including left ventricular ejection fraction (LVEF). Ultrasound assessments will generally be performed hourly under stable clinical conditions and additionally when significant circulatory changes occur. All participants will also undergo routine daily bedside echocardiography for comparison. In a subgroup of 400 participants (300 adults and 100 children), wearable ultrasound images will be displayed alongside electrocardiography, blood pressure, and oxygen saturation measurements on bedside monitors.
Agreement in Left Ventricular Ejection Fraction Measurements
Agreement between left ventricular ejection fraction (LVEF) measurements obtained using wearable ultrasound and conventional bedside echocardiography will be assessed using the intraclass correlation coefficient (ICC). Paired measurements will be used to evaluate the consistency of the two methods.
Time frame: Day 1
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Dec 2028, 25 months later.
Of 1,032 non-industry interventional studies with no phase under Cardiovascular Diseases, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 25 months is close to that.
Counting every sponsor, half of 1,148 studies reached it within 26 months; a quarter within 13 and three quarters within 49.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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China National Center for Cardiovascular Diseases →