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Clinical Trials in the USA / NCT07158450
Enrolling by invitation Observational

Novel On-body Evaluation of Cardiac Health for Oncology

NCT07158450 · tracked via the Priya Life Science USA tracker
Sponsor
Skribe Medical
Phase
Observational
Started
2025-10-09
Last updated
2026-10-05

Condition(s) studied

CardiotoxicityHeart Failure

Study summary

The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Undergoing an echocardiogram irrespective of participation in this study * Willing and able to provide informed consent prior to any study-related activity Exclusion Criteria: * Have a documented allergy to potential tissue contacting system materials * Have any condition that would cause inaccurate TTE measurements

Primary outcome measure(s)

  • Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates — From baseline through study completion (up to 6 months) at each paired assessment
    The primary analysis will compute the correlation coefficient (r) between wearable-derived model estimates of LVEF and transthoracic echocardiography-derived LVEF in the Hold-Out Test Set. The prespecified performance target is r \> 0.70.

Trial sites (11)

FacilityCityRegionStatus
Colorado Heart and Vascular Golden Colorado
South Denver Cardiology Littleton Colorado
Clearwater Cardiovascular Consultants Clearwater Florida
First Coast Cardiovascular Institute Jacksonville Florida
Midwest Cardiovascular Institute Naperville Illinois
Cardiovascular Institute of the South Houma Louisiana
Capital Cardiology Associates Albany New York
Strong Memorial Hospital Rochester New York
Cardiology Consultants of Philadelphia Yardley Pennsylvania
Stern Cardiovascular Center Germantown Tennessee
Virginia Commonwealth University Richmond Virginia

Other trials for the same condition

A Research Study Looking Into How Ziltivekimab Works Compared to Placebo in Participants With Heart Failure and Inflammation Active, not recruiting
BiVACOR® Total Artificial Heart Early Feasibility Study Recruiting
Assessment of CCM in HF With Higher Ejection Fraction Recruiting
Real World Effectiveness of the Cordella Pulmonary Artery Sensor System in Patients With Chronic Heart Heart Failure Recruiting
Assessment of Safety and Accuracy of the Microtech System in Patients Undergoing Left Ventricular Assist Device Implantation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07158450 on ClinicalTrials.gov ↗ ← All trials in the USA