Viewing Study NCT01515267



Ignite Creation Date: 2024-05-06 @ 12:13 AM
Last Modification Date: 2024-10-26 @ 10:46 AM
Study NCT ID: NCT01515267
Status: UNKNOWN
Last Update Posted: 2012-01-24
First Post: 2012-01-18

Brief Title: Automated Left Ventricular Function Evaluation by LVivoEF
Sponsor: DiA Imaging Analysis Ltd
Organization: DiA Imaging Analysis Ltd

Study Overview

Official Title: Automated Left Ventricular Function Evaluation by LVivoEF
Status: UNKNOWN
Status Verified Date: 2012-01
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: LVivoEF
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 andor 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
Detailed Description: LVivoEF is a decision support system software for automated global left ventricle LV systolic function evaluation from echocardiographic examinations LVivoEF technology is based on a novel image processing algorithm for LV edge detection and ejection fraction EF evaluation LVivoEF provides fully automated measurements of the left ventricle LV from two apical views the four chamber 4CH and the two chamber 2CH

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None