Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

Heart Failure Clinical Trial

Official title:

Comparison of the InCardia Venous Pressure Diagnostic Technology CorWatch With Swan Ganz Catheter Measurements in the Cardiac Catheterization Laboratory and Cardiac Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928326
• Other study ID #: CP-001A
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2024
• Source: InCardia Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational study to evaluate the agreement between the InCardia diagnostic technology CorWatch for the assessment of venous pressure in human subjects. This includes evaluation of InCardia technology in heart failure (HF) patients undergoing invasive right heart catheterization in a cardiac catheterization laboratory (cath lab) and in a cardiac intensive care unit (ICU).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosed with NYHA class II-IV heart failure irrespective of ejection fraction

• Patient is able to give consent

Exclusion Criteria:

• Severe tricuspid regurgitation

• Mechanical ventilation

• Patient is pregnant

• Inability to access either of the patient's upper arms.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Diagnostic Test:
• CorWatch
Non-invasive wearable monitor for the assessment of central venous pressure

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
InCardia Inc.	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement with right atrial pressure as measured by Swan Ganz catheter	Agreement between the CVP/RAP as assessed by the CorWatchTM method and the right arterial pressure (RAP) as measured by SG catheter	During the right heart catheterization procedure