Automated Left Ventricular Function Evaluation by LVivoEF

Left Ventricular Function Clinical Trial

— LVivoEF  

Official title:

Automated Left Ventricular Function Evaluation by LVivoEF

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01515267
• Other study ID #: DIA100
• Status: Active, not recruiting
• Phase: N/A
• First received: January 18, 2012
• Last updated: January 23, 2012
• Start date: November 2011

Study information

• Verified date: January 2012
• Source: Diacardio LTD
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Biplane EF Evaluation
• EF Evaluation From 2 Chamber Plane
• EF Evaluation From 4 Chamber Plane
• Left Ventricular Function

Locations

Country	Name	City	State
Israel	Soroka university medical center	Beer-Sheva

Sponsors (1)

Lead Sponsor	Collaborator
Diacardio LTD

Country where clinical trial is conducted

Israel,