NCT03642730

Brief Summary

This prospective study is a pilot study for evaluating a guidance system that aims to facilitate high-quality echocardiographic acquisitions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

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

December 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

May 9, 2018

Last Update Submit

February 2, 2021

Conditions

Cardiac DiseaseHeart FailureCardiac Ischemia

Keywords

echocardiographytrainingfollow-up

Outcome Measures

Primary Outcomes (4)

  • Echocardiography acquisition score [in %] [Operator's outcome]

    Composite measurement that characterizes the echocardiography acquisition of the operator who is being assessed with respect to a 2D reference acquisition The echocardiography acquisition score is a combination of the view type score and the image quality score

    Day 1

  • Time to acquisition [in seconds] [Operator's performance]

    Time to acquisition \[in seconds\] to reach an echocardiography acquisition score of 25%, 50%, 75% and 90%

    Day 1

  • Displacement [in mm] of the echocardiography probe with respect to the 2D reference acquisition [Technical reproducibility]

    Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the 2D reference acquisition \[Reproducibility of the probe position and orientation\]

    Day 1

  • Displacement [in mm] of the echocardiography probe with respect to the ideal acquisition [Geometrical reliability]

    Displacement \[in mm\] of the echocardiography probe at the acquisition time with respect to the ideal (geometrical) acquisition estimated from 3D reference acquisition \[Geometrical reliability of the probe position and orientation\]

    Day 1

Secondary Outcomes (1)

  • Left ventricular Ejection Fraction [in %] [Measurement reproducibility]

    Day 1

Study Arms (2)

Scanned patients

EXPERIMENTAL

Scanned patients TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors

Device: TransThoracic Echocardiography imaging

Non-expert scanning volunteers

EXPERIMENTAL

Non-expert scanning volunteers (among the medical staff at the clinical site) TransThoracic Echocardiography Diagnostic Test: TransThoracic Echocardiography imaging synchronized with additional external sensors

Device: TransThoracic Echocardiography imaging

Interventions

TransThoracic Echocardiography imagingDEVICE

ultrasound scanning

Non-expert scanning volunteersScanned patients

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All volunteers must have the ability to provide informed consent.
  • All volunteers should be affiliated to the French Social Security.
  • All volunteers will be scheduled for a routine transthoracic echocardiography exam in the echocardiography laboratory at the investigation site as part of standard care.

You may not qualify if:

  • Subjects with congenital heart diseases (except bicuspid aortic valve)
  • Pregnant women
  • Adults lacking decisional capacity
  • Adults placed under a legal protection regime (guardianship, curatorship, judicial protection)
  • Adults not affiliated to the French Social Security
  • Adults in emergent or critical condition
  • Adults with active pain in the intended scanning region
  • Adults with active skin disease or lesions in the intended scanning region
  • Adults with allergy/sensitivity to ultrasound gel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Caen Service de Cardiologie

Caen, 14033, France

Location

MeSH Terms

Conditions

Heart DiseasesHeart FailureCoronary Artery Disease

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Eric Saloux, MD

    Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Masking is not applicable, since software study
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2018

First Posted

August 22, 2018

Study Start

December 1, 2017

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)