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OpenTrials
Completed

NCT Number: NCT05673174

Avicena LVDP Validation Study in Healthy Volunteers

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

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Avicena

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects >21 years of age.
  • No known significant health problems.
  • Willing and able to participate in all study evaluations.
  • Ability to understand and sign informed consent.

Exclusion criteria

  • Open skin lesions at the site of Vivio application / examination.
  • Inability to obtain brachial artery blood pressure.

Treatment and study plan

Non-Invasive Estimation of Left Ventricular Diastolic Pressure

Diagnostic Test

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ventric Health, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2023
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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