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
1 other identifier
observational
43
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2021
CompletedFirst Posted
Study publicly available on registry
June 16, 2021
CompletedStudy Start
First participant enrolled
August 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedMarch 6, 2024
March 1, 2024
1.1 years
June 8, 2021
March 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Agreement with right atrial pressure as measured by Swan Ganz catheter
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
Study Arms (1)
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.
Interventions
Non-invasive wearable monitor for the assessment of central venous pressure
Eligibility Criteria
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.
You may qualify if:
- Diagnosed with NYHA class II-IV heart failure irrespective of ejection fraction
- Patient is able to give consent
You may not qualify if:
- Severe tricuspid regurgitation
- Mechanical ventilation
- Patient is pregnant
- Inability to access either of the patient's upper arms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InCardia Inc.lead
- University of California, San Franciscocollaborator
Study Sites (1)
University of California San Francisco
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2021
First Posted
June 16, 2021
Study Start
August 1, 2021
Primary Completion
September 1, 2022
Study Completion
October 1, 2022
Last Updated
March 6, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share