NCT07219693Recruiting

QuantaFlo HD Clinical Validation Study

Semler Scientific

Start Date

8/21/2025

Completion Date

6/30/2026

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 Criteria

Age Range: 22 years to No maximum

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

Interventions

DEVICE

QuantaFlo HD

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Conditions

To Assess Cardiovascular Function

Locations

Pima Heart and Vascular

Tucson, Arizona 85741

United States