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RecruitingNCT07219693Updated Oct 23, 2025

QuantaFlo HD Clinical Validation Study

An observational study in To Assess Cardiovascular Function, sponsored by Semler Scientific. Recruiting at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2025-10-23.

Sponsored by Semler Scientific · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
600
Ages
22 Years and older
Sex
All
01

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.

02

Conditions studied

  • To Assess Cardiovascular Function

Keywords

  • cardiovascular function
  • transthoracic echocardiography
  • global longitudinal strain
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In context

Lead sponsor

Semler Scientific is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No

Interventions

  • DeviceQuantaFlo HD

    blood flow at the finger during a forced expiration

06

What researchers measure

Primary outcomes

  1. Sensitivity and Specificity

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

    Time frame: From enrollment to the end of treatment is up to 1 week

Secondary outcomes

  1. Accuracy

    Accuracy comparing QuantaFlo HD test results to GLS findings

    Time frame: From enrollment to the end of treatment is up to 1 week

07

Study locations

1 of 1 sites recruiting
  • Pima Heart and Vascular
    Tucson, Arizona 85741, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07219693
Lead sponsor
Semler Scientific
Responsible party
Sponsor
First posted
Oct 22, 2025
Start date
Aug 21, 2025
Primary completion
Mar 31, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Oct 23, 2025

Study contacts

Gena Parker
Contact
gparker@semlerscientific.com
669-230-2729

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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