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Clinical Trials in the USA / NCT07219693
Recruiting Observational

QuantaFlo HD Clinical Validation Study

NCT07219693 · tracked via the Priya Life Science USA tracker
Sponsor
Semler Scientific
Phase
Observational
Started
2025-08-21
Last updated
2025-10-23

Condition(s) studied

To Assess Cardiovascular Function

Investigational drug(s) / intervention(s)

QuantaFlo HD

QuantaFlo HD: blood flow at the finger during a forced expiration

Study summary

The primary aim of this validation protocol is to assess cardiovascular function through transthoracic echocardiography ("Echo") measurements and the QuantaFlo HD test measuring blood flow at the finger during a forced expiration ("FE"). The study examines whether Echo-measured GLS values greater than -16% correlate with abnormal responses during FE as measured by QuantaFlo HD.

Eligibility

Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Male and female adult (≥ age 22) subjects with a minimum of 1 of the following: * A history of Cardiovascular Diseasei or PAD * Recorded history of at least two of the following * Hypertension * Diabetes * Hyperlipidemia Exclusion Criteria: * Unable to safely perform a forced expiration, or unable to obtain a technically adequate FE test result * Subjects with a pacemaker or ICD with pacemaker function * Terminal advanced illness * Recent cardiothoracic surgery (within 12 months) * Retinal eye disease with anticoagulants * History of eye surgery, within 90 days * Uncontrolled hypertension \>180 mmHg systolic pressure or \>100 mmHg diastolic pressure * Subjects with severe tremors

Primary outcome measure(s)

  • Sensitivity and Specificity — From enrollment to the end of treatment is up to 1 week
    Evaluate the sensitivity and specificity of QuantaFlo HD test results to GLS findings.

Trial sites (1)

FacilityCityRegionStatus
Pima Heart and Vascular Tucson Arizona 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 NCT07219693 on ClinicalTrials.gov ↗ ← All trials in the USA