QuantaFlo HD Clinical Validation Study

October 21, 2025 updated by: Semler Scientific
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Pima Heart and Vascular
        • Principal Investigator:
          • Thomas Waggoner
        • Principal Investigator:
          • Paul Bejarano
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study will be conducted at three clinical sites: one primary care clinic and one cardiac clinic, both with established echo referral pathways, and one dedicated echo clinic.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: 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.
From enrollment to the end of treatment is up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: From enrollment to the end of treatment is up to 1 week
Accuracy comparing QuantaFlo HD test results to GLS findings
From enrollment to the end of treatment is up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semler Scientific

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 21, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

October 20, 2025

First Submitted That Met QC Criteria

October 20, 2025

First Posted (Estimated)

October 22, 2025

Study Record Updates

Last Update Posted (Actual)

October 23, 2025

Last Update Submitted That Met QC Criteria

October 21, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 35-0262-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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