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

Completed

• Conditions: Patients Referred to St. Michael's Hospital Echocardiography Lab
• Interventions: Device: Mespere Venus 1000 System; Device: Echocardiography machine

• Registration Number: NCT01623986
• Lead Sponsor: Mespere Lifesciences Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-20
• Study Start: 2013-03
• Primary Completion: 2013-08
• Study Completion: 2013-09
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-14
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Age 18 and older
• Patient referred to St. Michael's Hospital Echocardiography Lab
• Signed written and informed consent

Exclusion Criteria

• Lack of patient consent
• Presence of known AV dialysis fistula
• Allergy to adhesive tape from Mespere Venus 1000 system
• Known central vein stenosis
• Unable to identify right external jugular vein
• Ongoing photodynamic therapy
• Assisted ventilation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
St. Michael's Hospital Patients	Mespere Venus 1000 System	Patients who are referred to the St. Michael's Hospital echocardiography (ECHO) lab.
St. Michael's Hospital Patients	Echocardiography machine	Patients who are referred to the St. Michael's Hospital echocardiography (ECHO) lab.

Primary Outcome Measures

Name	Time	Method
Right atrial pressure (RAP)	0-1 hour	To determine if the RAP from the non-invasive Mespere Venus 1000 System correlates with the RAP from an echocardiography (ECHO) machine

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada