Clinical Research Directory

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

Sponsor: Kunjing Pang

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). 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

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