QuantaFlo HD Clinical Validation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QuantaFlo HD.
- Who it may be relevant to
- Registry conditions: To Assess Cardiovascular Function. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device QuantaFlo HD
blood flow at the finger during a forced expiration
Primary outcome measures
- Sensitivity and Specificity [Time frame: From enrollment to the end of treatment is up to 1 week]
Secondary outcome measures (1)
- Accuracy [Time frame: From enrollment to the end of treatment is up to 1 week]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Pima Heart and Vascular — Tucson
Identifiers
NCT: NCT07219693 · 35-0262-01