Avicena LVDP Validation Study in Healthy Volunteers

NCT ID: NCT05673174

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

321 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-16

Study Completion Date

2022-08-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Non-Invasive Estimation of Left Ventricular Diastolic Pressure

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Avicena LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Avicena

Pasadena, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-0006

Identifier Type: -

Identifier Source: org_study_id

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