Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

NCT ID: NCT04928326

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-10-01

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CorWatch

Intervention Type DIAGNOSTIC_TEST

Non-invasive wearable monitor for the assessment of central venous pressure

Interventions

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CorWatch

Non-invasive wearable monitor for the assessment of central venous pressure

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role collaborator

InCardia Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP-001A

Identifier Type: -

Identifier Source: org_study_id

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