Avicena LVDP Validation Study in Healthy Volunteers

N/ACompletedNCT05673174

Avicena LLC321 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

321

Conditions

Healthy

Interventions

Non-Invasive Estimation of Left Ventricular Diastolic PressureDIAGNOSTIC_TEST

Modified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Avicena

Pasadena, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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