Novel On-body Evaluation of Cardiac Health for Oncology

NCT07158450 | Enrolling By Invitation

• 1 other identifier: SKR-LVEF-001
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiotoxicity; Heart Failure

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (1)

• Clinical accuracy of wearable-derived LVEF compared with echocardiography

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

Study Arms (3)

Healthy

No known or suspected cardiac disease

Borderline LVEF

Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction

Reduced LVEF

Known diagnosis of reduced left ventricular ejection fraction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) recruited from participating cardiology clinics. Participants are assigned to one of three cohorts by transthoracic echocardiography (TTE): Healthy (no known structural heart disease; LVEF ≥ 55%), Borderline/Possibly reduced LVEF (LVEF 40-54% or clinical concern for decline), and Reduced LVEF (LVEF \< 40%). The population is intended to span the full spectrum of systolic function for model training and evaluation.

You may qualify if:

• Undergoing an echocardiogram irrespective of participation in this study
• Willing and able to provide informed consent prior to any study-related activity

You may not qualify if:

• Have a documented allergy to potential tissue contacting system materials
• Have any condition that would cause inaccurate TTE measurements

Sponsors & Collaborators

• Skribe Medical: lead
• University of Rochester: collaborator

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Cardiotoxicity; Heart Failure

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2025
• First Posted: September 5, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)