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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT01623986
First received: June 18, 2012
Last updated: August 14, 2014
Last verified: August 2014
History of Changes
  Purpose
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.

Condition Intervention
Patients Referred to St. Michael's Hospital Echocardiography Lab
 Device: Mespere Venus 1000 System
Device: Echocardiography machine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mespere Lifesciences Inc.:

Primary Outcome Measures:
  • Right atrial pressure (RAP) [ Time Frame: 0-1 hour ] [ Designated as safety issue: No ]
    To determine if the RAP from the non-invasive Mespere Venus 1000 System correlates with the RAP from an echocardiography (ECHO) machine
Enrollment: 45
Study Start Date: March 2013
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
St. Michael's Hospital Patients
Patients who are referred to the St. Michael's Hospital echocardiography (ECHO) lab.
 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).
Other Name: ECHO machine

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.

  Eligibility
Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients referred to St. Michael's Hospital echocardiography lab
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623986

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Mespere Lifesciences Inc.
Investigators
Principal Investigator: Chi-Ming Chow, MD St. Michael's Hospital, Toronto
  More Information

Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT01623986     History of Changes
Other Study ID Numbers: MLS STP-9000010 
Study First Received: June 18, 2012
Last Updated: August 14, 2014
Health Authority: Canada: Health Canada

ClinicalTrials.gov processed this record on September 26, 2016