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NCT05673174 Clinical Trial

Avicena LVDP Validation Study in Healthy Volunteers

Healthy Clinical Trial

Official title:
Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05673174
Other study ID # CP-0006
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 16, 2022
Est. completion date August 30, 2022

Study information
Verified date November 2022
Source Avicena LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 321
Est. completion date August 30, 2022
Est. primary completion date August 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Adult subjects >21 years of age. 2. No known significant health problems. 3. Willing and able to participate in all study evaluations. 4. Ability to understand and sign informed consent. Exclusion Criteria: 1. Open skin lesions at the site of Vivio application / examination. 2. Inability to obtain brachial artery blood pressure.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Non-Invasive Estimation of Left Ventricular Diastolic Pressure
Modified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP

Locations
Country Name City State
United States Avicena Pasadena California

Sponsors (1)
Lead Sponsor Collaborator
Avicena LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set. 3 months
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