Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04928326

Enrollment

Registered

2021-06-16

Start date

2021-08-01

Completion date

2022-10-01

Last updated

2024-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

central venous pressure, right heart catheterization, hemodynamic congestion

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).

Interventions

DIAGNOSTIC_TESTCorWatch

Non-invasive wearable monitor for the assessment of central venous pressure

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026