Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure
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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 |
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Recruitment Status :
Enrolling by invitation
First Posted : June 16, 2021
Last Update Posted : December 7, 2021
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Sponsor:
InCardia Inc.
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
InCardia Inc.
| Tracking Information | |||||||||
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| 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 |
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
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| 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 |
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| 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
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| 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
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Enrolling by invitation | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 |
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| IPD Sharing Statement |
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| 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 | ||||||||