NCT01623986

Correlation of Measurements From Mespere Venus 1000 System & Echocardiography to Estimate Right Atrial Pressure

Technical Correlation of a Noninvasive Estimation of Central Venous Pressure From the Mespere Venus 1000 System and the Inferior Vena Cava From Echocardiography, to Estimate Right Atrial Pressure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Mespere Lifesciences Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to investigate if central venous pressure (CVP) measurements from the Mespere Venus 1000 System can be used for right atrial pressure (RAP) when estimating right ventricular systolic pressure (RVSP) in echocardiography labs.

Detailed description

The non-invasive assessment of the pressure on the right side of your heart using an imaging machine called a Doppler echocardiography machine (also known as an ECHO machine) is a widely accepted technique and is used as a screening tool for pulmonary hypertension and heart failure. The pressure on this side of your heart reflects the pressure of the blood in your veins returning to your heart and the effectiveness of your heart to pump that blood to your lungs. The accuracy of this technique depends on making an accurate estimate of the pressure in the upper chamber (atrium) of the right side of your heart, known as your right atrial pressure (RAP). Right atrium pressure can be measured non-invasively by imaging of your heart using an echocardiography (aka ECHO) machine. But the technique depends on the skills of the sonographer (the person who operates the ECHO machine) and can take considerable time to complete. In view of this limitation, a non-invasive technique that could be used to make the RAP measurements may be more reliable and/or faster than the current technique. Mespere Lifesciences Inc. has developed a new non-invasive device that is expected to allow for a simple, rapid and reliable measurement of RAP. The device consists of a set of light sensors on a patch that is placed onto the surface of the patient's right side of the neck.

Conditions

• Patients Referred to St. Michael's Hospital Echocardiography Lab

Interventions

Type	Name	Description
DEVICE	Mespere Venus 1000 System	An adhesive patch (connected to the Mespere Venus 1000 System) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with right atrial pressure values obtained by echocardiography(standard clinical practice)
DEVICE	Echocardiography machine	Use of ultrasound to estimate right atrial pressure from analyzing inferior vena cava (IVC).

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2012-06-20
• Last updated: 2014-08-15

Locations

1 site across 1 country: Canada