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Comparison of non-invasive vs. invasive hemodynamic measurements Phase II

Study Type/Phase: Feasibility
Status: Recruiting

Heart Failure (HF) is a clinical syndrome caused by structural and functional defects in myocardium (heart muscle) resulting in impairment of ventricular filling (diastolic dysfunction) or the ejection of blood (systolic dysfunction). The result is insufficient blood flow to provide adequate oxygenation to body organs. The symptoms range from ‘silent’ heart failure to Congestive Heart Failure (CHF). The symptoms of CHF range from increasing fatigue, heart palpitations (rapid heart beats), dyspnea (shortness of breath), swelling of extremities and weight gain, all resulting in possible hospitalization and eventually death. Timely diagnosis and appropriate management of CHF has the potential to optimize quality of life and reduce HF-related hospitalizations and complications.

This will be the second phase of the study for developing a new method to assess hemodynamic (dynamics of blood flow) status non-invasively. The first phase of the study compared the data in a population of 33 individuals. This second part will add an additional 60 patients to that number, for a total of 93. The primary endpoint of the first phase of the study was to evaluate whether the non-invasive hemodynamic measurement correlates with the invasive hemodynamic measurement. This second phase will be evaluating whether ezCVP values can separate patients into two groups: Low CVP and high CVP.

Approximately 60 (90 total) patients will be enrolled at the El Camino Health Mountain View hospital location.

Speak with your doctor to determine whether you meet the following criteria for participation in this study.

Inclusion Criteria Exclusion Criteria
  • Adult age over 18 years
  • Arm circumference is 23 cm to 55 cm
  • Subject will have a central venous catheter
  • Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
  • Subject or LAR is willing and able to comply with protocol procedures
  • Finger and upper arm anatomical anomaly or disease that may interfere with attaching non-invasive measurement devices
  • Pregnant (self-reported)
  • Upper extremity DVT (currently being treated)
  • Severe skin disease involving the upper arm(s)
  • Study investigator may exclude patients based on clinical judgment

Principal Investigator

Zachary Edmonds, MD

Sponsor

Nihon Kohden Corporation

 

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