NCT04807985

Brief Summary

The JVPHome is a novel medical device that utilizes machine vision in order to facilitate assessment of jugular venous pressure (JVP) height relative to the sternal angle with the ultimate goal of enabling remote JVP monitoring. The current study aims to evaluate the ability of the JVPHome to enable remote identification of JVP height relative to ultrasound among congestive heart failure (CHF) patients when the device is applied by the study team in the clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

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

Study Start

First participant enrolled

January 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

March 16, 2021

Last Update Submit

March 22, 2022

Conditions

Congestive Heart Failure

Keywords

Jugular Venous Pressure, Remote Monitoring, Machine Vision, Telemedicine

Outcome Measures

Primary Outcomes (1)

  • Accuracy of JVP assessment using the JVPHome

    Correlation between JVP height assessed by JVPHome and ultrasound

    Baseline

Secondary Outcomes (2)

  • Agreement between JVPHome and ultrasound

    Baseline

  • JVP Visualization

    Baseline

Study Arms (1)

Ambulatory CHF patients

Patients visiting an outpatient CHF clinic

Device: JVPHome and ultrasound

Interventions

JVPHome and ultrasoundDEVICE

Remote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients.

Ambulatory CHF patients

Eligibility Criteria

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

Ambulatory CHF outpatients followed at the specialty heart failure clinic at Eastern Health in St. John's, Newfoundland and Labrador, Canada

You may qualify if:

  • Age \>/= 18 years
  • Congestive heart failure diagnosis receiving ongoing treatment
  • Able to provide informed consent

You may not qualify if:

  • \. Conditions which preclude visualization of the JVP, including neck deformity, scarring, and facial hair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Health

St. John's, Newfoundland and Labrador, A1B 2X5, Canada

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Kris Aubrey-Bassler, MD

    Eastern Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 19, 2021

Study Start

January 1, 2021

Primary Completion

August 30, 2021

Study Completion

October 1, 2021

Last Updated

March 23, 2022

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)