Avicena LVDP Validation Study

Heart Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05633004
• Other study ID #: CP-0001
• Status: Completed
• Phase: N/A
• Start date: September 27, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2022
• Source: Avicena LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Prospective study to document the utility of Vivio in quantifying LVDP, using directly measured LVDP collected during left heart catheterization as the comparator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: September 30, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Adult subjects >21 years of age.

2. 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.

3. Willing and able to participate in all study evaluations and allow access to medical records, including medical testing records.

4. Ability to understand and sign informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.

Exclusion Criteria:

1. Acute coronary syndrome, or documented MI within a week of scheduled catheterization, cardiogenic shock, or the need for intravenous inotropic or mechanical circulatory support.

2. Carotid pulse is not palpable by a trained study researcher.

3. History of carotid sinus hypersensitivity (fainting in response to minimal touching or positioning of the neck).

4. 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.

5. Open skin lesions at the site of Vivio application / examination.

6. Contraindication to placing a catheter in the LV in the judgement of the investigator (e.g., mechanical aortic valve, left ventricular thrombus, etc.).

7. Inability to obtain brachial artery blood pressure.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Vivio
Non-invasive estimation of Left-Ventricular End Diastolic Pressure (LVEDP)

Locations

Country	Name	City	State
United States	Spectrum	Grand Rapids	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Avicena LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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