Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

March 4, 2024 updated by: InCardia Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with heart failure undergoing right heart catheterization
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.
Diagnostic test: CorWatch
Non-invasive wearable monitor for the assessment of central venous pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
During the right heart catheterization procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InCardia Inc.

Collaborators

University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

September 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Estimated)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-001A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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