NCT05441696

Study for the Evaluation of a Non-invasive Hemodynamic Measurement in Heart Failure Patients

Pilot Study for the Evaluation of EzCVP in Heart Failure Patients

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 65 (estimated)
• Sponsor: Nihon Kohden · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Track changes in non-invasive central venous pressure across hospital stay and relationship with readmission

Detailed description

Determining the degree of congestion is important in deciding appropriate timing for discharging hospitalized heart failure patients. Central venous pressure (CVP) reflects the returning blood volume to the heart and can guide therapy to relieve congestion. However, the conventional method used to measure CVP has notable limitations as it is an invasive procedure that requires placement of a central venous catheter. Traditional, non-invasive methods of estimating CVP, such as physical examination and echocardiogram, are less accurate and more resource intensive. To overcome this challenge, new technology to assess CVP non-invasively using an oscillometric method has been developed. This new technology involves measurement of the enclosed zone central venous pressure (ezCVP), which, in a preclinical study, has been shown to correlate with invasive data. Additionally, a previous correlation study demonstrated that the ezCVP value can be mathematically adjusted to estimate invasive CVP. The resulting value has been termed CVPNI (CVP Non-Invasive). Most recently, a limited pilot study of patients hospitalized with acute, decompensated heart failure demonstrated the feasibility of device use in this population and the expected and incremental fall in CVPNI with medical treatment over the course of hospitalization. Moving forward, and in order to further improve the care of patients hospitalized with heart failure, an expanded pilot study of ezCVP technology is needed to prove that changes in CVPNI track with these patients' condition during admission and can be useful in their clinical care.

Conditions

• Congestive Heart Failure

Interventions

Type	Name	Description
DEVICE	ezCVP measurement	* Measuring device: non-FDA-cleared patient monitor (740E, Zoe Medical, MA, US), which has software to measure ezCVP. * Sensor: an FDA-cleared pulse oximeter sensor for adults (K012891: DS-100A, Nellcor, CA, US). * Cuff: an FDA-cleared NIBP cuff for adults (K080342: YP-713T, YP-714T or TP-715T, Nihon Kohden Corporation, Tokyo, Japan).

Timeline

• Start date: 2022-06-01
• Primary completion: 2025-09-30
• Completion: 2026-09-29
• First posted: 2022-07-01
• Last updated: 2024-12-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study