Comparison of CorWatch With Right Heart Catheter Measurements in Heart Failure

InCardia

Status: Completed

Conditions: Heart Failure

Treatments: Diagnostic Test: CorWatch

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04928326

CP-001A

Details and patient eligibility

About

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).

Enrollment: 43 patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

43 participants in 1 patient group

Patients with heart failure undergoing right heart catheterization

Description:

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.

Treatment:

Diagnostic Test: CorWatch