To Assess Cardiovascular FunctionNCT07219693
QuantaFlo HD Clinical Validation Study
An observational study of To Assess Cardiovascular Function, run by Semler Scientific at 1 site in United States.
Trial 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"). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- To Assess Cardiovascular Function
- What is being tested?
- QuantaFlo HD
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pima Heart and Vascular
Tucson, Arizona, 85741
Monica Varela, 520-975-6400, Monica.Varela@usheartandvascular.com
Thomas Waggoner
About this study
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.
- Conditions
- To Assess Cardiovascular Function
- Being tested
- QuantaFlo HD
- Keywords
- cardiovascular function, transthoracic echocardiography, global longitudinal strain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantaFlo HDDevice
blood flow at the finger during a forced expiration
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity
Evaluate the sensitivity and specificity of QuantaFlo HD test results to GLS findings.
Measured: 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
Measured: From enrollment to the end of treatment is up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start21 Aug 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for To Assess Cardiovascular FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semler Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219693
- Sponsor's protocol ID
- 35-0262-01
- Status last verified
- Oct 2025
- First submitted
- 20 Oct 2025
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- QuantaFlo HD Clinical Validation Study
- ClinicalTrials.gov ID
- NCT07219693
- Acronym / sponsor ID
- 35-0262-01
- Conditions
- To Assess Cardiovascular Function
- Keywords
- cardiovascular function, transthoracic echocardiography, global longitudinal strain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Semler ScientificIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuantaFlo HDblood flow at the finger during a forced expiration | Device | – |
Primary outcome
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.
1 secondary outcome
Accuracy
Time frame: From enrollment to the end of treatment is up to 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of To Assess Cardiovascular Function, run by Semler Scientific at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gena Parker (669-230-2729, gparker@semlerscientific.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity (time frame: From enrollment to the end of treatment is up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.