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Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04928326
Recruitment Status : Enrolling by invitation
First Posted : June 16, 2021
Last Update Posted : December 7, 2021
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
InCardia Inc.

Study Description
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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
Heart Failure Diagnostic Test: CorWatch

Study Design
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Study Type : Observational
Estimated 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 : August 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04928326


Locations
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United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
InCardia Inc.
University of California, San Francisco
More Information
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Responsible Party: InCardia Inc.
ClinicalTrials.gov Identifier: NCT04928326    
Other Study ID Numbers: CP-001A
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by InCardia Inc.:
central venous pressure
right heart catheterization
hemodynamic congestion
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases