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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-09-30

Brief Summary

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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.

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Detailed Description

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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

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Patients Referred to St. Michael's Hospital Echocardiography Lab

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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St. Michael's Hospital Patients

Patients who are referred to the St. Michael's Hospital echocardiography (ECHO) lab.

Mespere Venus 1000 System

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Interventions

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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)

Intervention Type DEVICE

Echocardiography machine

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

Intervention Type DEVICE

Other Intervention Names

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ECHO machine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No