Pima Heart and Vascular
Tucson, Arizona, 85741, United States
Location status: Recruiting
Location contact
Monica Varela
CONTACT
Paul Bejarano
PRINCIPAL_INVESTIGATOR
Thomas Waggoner
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07219693
QuantaFlo HD Clinical Validation 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
22 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
QuantaFlo HD
Deviceblood flow at the finger during a forced expiration
Primary outcomes
-
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.
Secondary outcomes
-
Accuracy
Time frame: From enrollment to the end of treatment is up to 1 week
Accuracy comparing QuantaFlo HD test results to GLS findings
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Semler Scientific
Industry
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Oct 22, 2025
- Registry last updated
- Oct 23, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.