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

M

Mespere Lifesciences

Status

Completed

Conditions

Patients Referred to St. Michael's Hospital Echocardiography Lab

Treatments

Device: Echocardiography machine
Device: Mespere Venus 1000 System

Study type

Observational

Funder types

Industry

Identifiers

NCT01623986
MLS STP-9000010

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

45 participants in 1 patient group

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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