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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.

Tracking Information
First Submitted Date June 8, 2021
First Posted Date June 16, 2021
Last Update Posted Date December 7, 2021
Actual Study Start Date August 1, 2021
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 14, 2021)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure
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
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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Heart Failure
Intervention Diagnostic Test: CorWatch
Non-invasive wearable monitor for the assessment of central venous pressure
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: CorWatch
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: June 14, 2021)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 1, 2022
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04928326
Other Study ID Numbers CP-001A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party InCardia Inc.
Original Responsible Party Same as current
Current Study Sponsor InCardia Inc.
Original Study Sponsor Same as current
Collaborators University of California, San Francisco
Investigators Not Provided
PRS Account InCardia Inc.
Verification Date December 2021