NCT01515267

Brief Summary

Left ventricular ejection fraction (EF) is evaluated in every echocardiographic examination either by visual estimation (eyeballing) requiring high level of training and expertise and/or by manual tracing of the endocard from which EF is calculated (manual biplane method (MBP)). This procedure is subjective and time consuming. The objective of this study is to compare the performance of LVivoEF software system to the measurements obtained by the routinely used methods.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

First QC Date

January 18, 2012

Last Update Submit

January 23, 2012

Conditions

EF Evaluation From 4 Chamber PlaneEF Evaluation From 2 Chamber PlaneBiplane EF EvaluationLeft Ventricular Function

Keywords

EFEDVESVBiplaneEchocardiography

Eligibility Criteria

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

patients referred to an echocardiographic examination

You may qualify if:

  • Age \> 18
  • Patients referred to an echocardiographic examination. The patients will be consecutive until 30% of patients with normal LV function are enrolled. After that only consecutive patients with abnormal LV function will be included.

You may not qualify if:

  • Examinations in which more than one third of the endocard is not visible in a plane (2CH/4CH)
  • Patients with Left bundle branch block (LBBB)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka university medical center

Beersheba, Israel

Location

Study Officials

  • Noah Liel-Cohen, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

November 1, 2011

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations

IL(1)