Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure
Completed
- Conditions
- Heart Failure
- Interventions
- Diagnostic Test: CorWatch
- 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
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
- Arm && Interventions
Group Intervention Description Patients with heart failure undergoing right heart catheterization CorWatch Subjects with a diagnosis of NYHA class II-IV heart failure who meet the inclusion and exclusion criteria will be eligible for participation in this study.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California San Francisco
🇺🇸San Francisco, California, United States