Avicena LVDP Validation Study in Healthy Volunteers

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05673174

Enrollment

321

Registered

2023-01-06

Start date

2022-06-16

Completion date

2022-08-30

Last updated

2023-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

left ventricular diastolic pressure

Brief summary

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

Interventions

DIAGNOSTIC_TESTNon-Invasive Estimation of Left Ventricular Diastolic Pressure

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026