Novel On-body Evaluation of Cardiac Health for Oncology

Launched by SKRIBE MEDICAL ·

Keywords

ClinConnect Summary

This is an early-stage, observational study to see if a wearable sensor can accurately estimate how well the heart pumps (left ventricular ejection fraction, or LVEF) compared with the standard ultrasound test (echocardiography). The study plans to enroll about 50 adults from cardiology clinics and will compare wearable-based LVEF estimates to echocardiography results over a period of up to 6 months. The main goal is to see how closely the wearable measurements match the echo results, with a target correlation greater than 0.70.

Participants will be adults (18 and older) of any sex who are undergoing an echocardiogram and can give informed consent. They will be grouped into three categories based on their echo results: Healthy (LVEF 55% or higher), Borderline (40–54%), and Reduced LVEF (<40%). Exclusions include certain heart conditions that could distort results, such as severe valve disease or active ischemia, allergies to device materials, or having an implanted cardiac device. Participants will wear the sensor device, have paired assessments with echocardiography, and researchers will assess how accurate the wearable is by comparing it to the echo results. The study is sponsored by Skribe Medical with the University of Rochester, results are not yet available, and individual data will not be shared. Recruitment is planned to start around September 2025, with completion expected in March 2026.

Gender

ALL

Eligibility criteria