Avicena LVDP Validation Study

NCT05633004 | Completed FDA Device

• 1 other identifier: CP-0001
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Interventions

Vivio DEVICE

Non-invasive estimation of Left-Ventricular End Diastolic Pressure (LVEDP)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Avicena LLC: lead

Study Sites (1)

Spectrum

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: September 27, 2021
• Primary Completion: September 8, 2022
• Study Completion: September 30, 2022
• Last Updated: December 1, 2022

Record last verified: 2022-11

Locations

US (1)