Trials / Completed
CompletedNCT05633004
Avicena LVDP Validation Study
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 406 (actual)
- Sponsor
- Avicena LLC · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vivio | Non-invasive estimation of Left-Ventricular End Diastolic Pressure (LVEDP) |
Timeline
- Start date
- 2021-09-27
- Primary completion
- 2022-09-08
- Completion
- 2022-09-30
- First posted
- 2022-12-01
- Last updated
- 2022-12-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05633004. Inclusion in this directory is not an endorsement.