Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

Completed

• Conditions: Heart Failure

• Registration Number: NCT04928326
• Lead Sponsor: InCardia Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-14
• Study First Posted: 2021-06-16
• Study Start: 2021-08-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement with right atrial pressure as measured by Swan Ganz catheter	During the right heart catheterization procedure	Agreement between the CVP/RAP as assessed by the CorWatchTM method and the right arterial pressure (RAP) as measured by SG catheter

Trial Locations

Locations (1)

University of California San Francisco; 🇺🇸 San Francisco, California, United States