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

Patients Referred to St. Michael's Hospital Echocardiography Lab Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01623986
• Other study ID #: MLS STP-9000010
• Status: Completed
• Phase: N/A
• First received: June 18, 2012
• Last updated: August 14, 2014
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: August 2014
• Source: Mespere Lifesciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

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)
• Echocardiography machine
Use of ultrasound to estimate right atrial pressure from analyzing inferior vena cava (IVC).

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mespere Lifesciences Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Right atrial pressure (RAP)	To determine if the RAP from the non-invasive Mespere Venus 1000 System correlates with the RAP from an echocardiography (ECHO) machine	0-1 hour	No