Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

Sponsor

InCardia Inc. (Industry)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04928326

Collaborator

University of California, San Francisco (Other)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Diagnostic Test: CorWatch

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official 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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

InCardia Inc.
University of California, San Francisco

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

InCardia Inc.

ClinicalTrials.gov Identifier:

NCT04928326

Other Study ID Numbers:

CP-001A

First Posted:

Jun 16, 2021

Last Update Posted:

Dec 7, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by InCardia Inc.

central venous pressure

right heart catheterization

hemodynamic congestion

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Dec 7, 2021