NCT01623986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

5 months

First QC Date

June 18, 2012

Last Update Submit

August 14, 2014

Conditions

Patients Referred to St. Michael's Hospital Echocardiography Lab

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

St. Michael's Hospital Patients

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

Device: Mespere Venus 1000 SystemDevice: Echocardiography machine

Interventions

Mespere Venus 1000 SystemDEVICE

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)

St. Michael's Hospital Patients
Echocardiography machineDEVICE

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

Also known as: ECHO machine
St. Michael's Hospital Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients referred to St. Michael's Hospital echocardiography lab

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Study Officials

  • Chi-Ming Chow, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

CA(1)