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
1 other identifier
observational
321
1 country
1
Brief Summary
The purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedFirst Submitted
Initial submission to the registry
December 21, 2022
CompletedFirst Posted
Study publicly available on registry
January 6, 2023
CompletedJanuary 6, 2023
November 1, 2022
3 months
December 21, 2022
December 21, 2022
Conditions
Keywords
Outcome Measures
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.
3 months
Interventions
Modified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP
Eligibility Criteria
Healthy Volunteers, no history of Heart Disease.
You may qualify if:
- 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.
You may not qualify if:
- Open skin lesions at the site of Vivio application / examination.
- Inability to obtain brachial artery blood pressure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avicena LLClead
Study Sites (1)
Avicena
Pasadena, California, 91105, United States
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2022
First Posted
January 6, 2023
Study Start
June 16, 2022
Primary Completion
August 30, 2022
Study Completion
August 30, 2022
Last Updated
January 6, 2023
Record last verified: 2022-11