Novel On-body Evaluation of Cardiac Health for Oncology

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.

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Key information

Conditions

Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Heart Failure Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Colorado Heart and Vascular, Golden, Colorado, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates

Time frame: 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.

Secondary outcomes

Clinical accuracy of wearable-derived LVEF compared with echocardiography

Time frame: From baseline through study completion (up to 6 months) at each paired assessment

Proportion of predictions within ±5 percentage points of TTE-derived LVEF in the Hold-Out Test Set. Error metrics will be calculated as Mean Absolute Error (MAE) between wearable-derived and TTE-derived LVEF. Differences across subgroups will be tested with ANOVA or Kruskal-Wallis as appropriate. Prespecified performance target: MAE ≤ 5 percentage points.

Sponsors and collaborators

Lead sponsor

Skribe Medical

Industry

Collaborators

University of Rochester

Registry information

Official study title

Evaluation of Wearable Sensor-Based Estimation of Left Ventricular Ejection Fraction (LVEF) - Pilot Study

Acronym: NOECHO

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Sep 5, 2025
Registry last updated: May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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