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Avicena LVDP Validation Study

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivio
Sponsored by
Avicena LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult subjects >21 years of age. Referred for non-emergent left heart catheterization inclusive of direct measurement of LVDP as part of routine clinical management, to be performed from a femoral or radial access site. Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records. Ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject. Exclusion Criteria: Acute coronary syndrome, or documented MI within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support. Carotid pulse is not palpable by a trained study researcher. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck). History of significant or symptomatic carotid artery disease, including TIA, ultrasound evidence of >60% carotid stenosis, or at the discretion of the investigator; history of carotid artery stenting or surgery. Open skin lesions at the site of Vivio application / examination. Contraindication to placing a catheter in the LV in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.). Inability to obtain brachial artery blood pressure.

Sites / Locations

  • Spectrum

Outcomes

Primary Outcome Measures

The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts
The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
November 21, 2022
Sponsor
Avicena LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05633004
Brief Title
Avicena LVDP Validation Study
Official Title
Assessment of the Vivio System for the Non-Invasive Estimation of Left Ventricular Diastolic Pressure (LVDP) as an Aid in the Diagnosis of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
September 8, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avicena LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to determine the relationship between non-invasive measurement of left ventricular diastolic pressure (LVDP) using the Vivio System, compared with invasively measured LVDP via direct measurement during left heart catheterization.
Detailed Description
Prospective study to document the utility of Vivio in quantifying LVDP, using directly measured LVDP collected during left heart catheterization as the comparator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective
Masking
None (Open Label)
Allocation
N/A
Enrollment
406 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vivio
Intervention Description
Non-invasive estimation of Left-Ventricular End Diastolic Pressure (LVEDP)
Primary Outcome Measure Information:
Title
The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts
Description
The primary endpoints are the sensitivity and specificity of the Vivio Cuff System for predicting elevated versus non elevated LVEDP as compared to direct measurement of LVEDP in the combined Cath Lab and Healthy Cohorts
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects >21 years of age. Referred for non-emergent left heart catheterization inclusive of direct measurement of LVDP as part of routine clinical management, to be performed from a femoral or radial access site. Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records. Ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject. Exclusion Criteria: Acute coronary syndrome, or documented MI within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support. Carotid pulse is not palpable by a trained study researcher. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck). History of significant or symptomatic carotid artery disease, including TIA, ultrasound evidence of >60% carotid stenosis, or at the discretion of the investigator; history of carotid artery stenting or surgery. Open skin lesions at the site of Vivio application / examination. Contraindication to placing a catheter in the LV in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.). Inability to obtain brachial artery blood pressure.
Facility Information:
Facility Name
Spectrum
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Avicena LVDP Validation Study

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