Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Prospective study to document the utility of Vivio in quantifying LVDP, using directly measured LVDP collected during left heart catheterization as the comparator.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivio | Device | Non-invasive estimation of Left-Ventricular End Diastolic Pressure (LVEDP) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spectrum | Grand Rapids | Michigan | 49503 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Prospective
Not provided
Not provided
Not provided
Not provided