RecruitingNCT07219693
QuantaFlo HD Clinical Validation Study
Sponsor
Semler Scientific
Enrollment
600 participants
Start Date
Aug 21, 2025
Study Type
OBSERVATIONAL
Conditions
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.
Eligibility
Min Age: 22 Years
Inclusion Criteria6
- 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 Criteria8
- 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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Interventions
DEVICEQuantaFlo HD
blood flow at the finger during a forced expiration
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07219693