QuantaFlo HD Clinical Validation Study for Cardiovascular Function

This study is looking at a new device called QuantaFlo HD. It measures blood flow in your finger during a forced breath to assess how well your heart and blood vessels are working (cardiovascular function). Researchers want to see if the QuantaFlo HD test results match up with a different heart test called an echocardiogram (Echo). You might be able to join if you are an adult (22 years or older) with a history of heart disease, peripheral artery disease (PAD), or at least two conditions like high blood pressure (hypertension), diabetes, or high cholesterol (hyperlipidemia). The study aims to enroll 600 people, but its current status is unclear.

Study design
This is an observational study, meaning researchers will observe and collect information without giving you a specific treatment. It plans to include 600 participants.
What's involved
You would need to perform a forced expiration test that is technically adequate. The study duration from enrollment to the end of treatment is up to 1 week.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured from enrollment to the end of treatment, which is up to 1 week.

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NCT07219693

QuantaFlo HD Clinical Validation Study

Recruiting
Not specifiedAges 22+Observational
Semler Scientific
~600 participants
Updated 2025-10-23 on ClinicalTrials.gov
What's tested:QuantaFlo HD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and Specificity
Measured over From enrollment to the end of treatment is up to 1 week
To Assess Cardiovascular Function
1 sites across 1 states
Arizona1

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Eligibility criteria

Inclusion

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

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
  • Sensitivity and SpecificityFrom enrollment to the end of treatment is up to 1 week

    Evaluate the sensitivity and specificity of QuantaFlo HD test results to GLS findings.