Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

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).

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CorWatch

Diagnostic Test

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

Primary outcomes

Agreement with right atrial pressure as measured by Swan Ganz catheter

Time frame: 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

Sponsors and collaborators

Lead sponsor

InCardia Inc.

Industry

Collaborators

University of California, San Francisco

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 16, 2021
Registry last updated: Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed