Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions

NCT02003040 | Unknown

• 1 other identifier: STP-9000011
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the utility of Venus 1000 in predicting 30-day hospital readmissions for acute decompensated heart failure. Secondary outcomes will include correlation with NT-proBNP and weight both at admission and discharge from hospital

Conditions

ADHF

Outcome Measures

Primary Outcomes (1)

• Change from baseline in non-invasive central venous pressure (NICVP) at time of hospital discharge

  To determine if NICVP (taken at time of hospital admission and discharge) from the Mespere Venus 1000 CVP System can predict 30-day hospital readmissions for acute decompensated heart failure.

  time of hospital admission (baseline) and time of hospital discharge

Secondary Outcomes (2)

• NT-proBNP

  1 visit

• Patient's weight

  1 visit

Study Arms (1)

St. Michael's Hospital Patients

Patients admitted to the Cardiology ward at St Michael's Hospital with a main diagnosis of acute decompensated heart failure

Device: Mespere Venus 1000 CVP System

Interventions

Mespere Venus 1000 CVP System DEVICE

An adhesive patch (connected to the Mespere Venus 1000 System) is placed on the neck of the subject. A CVP measurement is recorded at time of patient's hospital admission and discharge. CVP readings will remain concealed from the treating team.

St. Michael's Hospital Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the Cardiology ward at St Michael's Hospital with a main diagnosis of acute decompensated heart failure.

You may qualify if:

• Age 18 and older
• Patient admitted to St. Michael's Hospital with a main clinical diagnosis of decompensated heart failure.
• Signed 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.
• Ongoing photodynamic therapy.
• Assisted ventilation.
• Associated acute coronary syndrome

Sponsors & Collaborators

• Mespere Lifesciences Inc.: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Study Officials

• Abdul Al-Hesayen, 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: December 2, 2013
• First Posted: December 6, 2013
• Study Start: September 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

CA (1)