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Automated Left Ventricular Function Evaluation by LVivoEF (LVivoEF)

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ClinicalTrials.gov Identifier: NCT01515267
Recruitment Status : Unknown
Verified January 2012 by Diacardio LTD.
Recruitment status was:  Active, not recruiting
First Posted : January 24, 2012
Last Update Posted : January 24, 2012
Sponsor:
Information provided by (Responsible Party):
Diacardio LTD

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.

Condition or disease
EF Evaluation From 4 Chamber Plane EF Evaluation From 2 Chamber Plane Biplane EF Evaluation Left Ventricular Function

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 Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Automated Left Ventricular Function Evaluation by LVivoEF
Study Start Date : November 2011




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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients referred to an echocardiographic examination
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515267


Locations
Israel
Soroka university medical center
Beer-Sheva, Israel
Sponsors and Collaborators
Diacardio LTD
Investigators
Principal Investigator: Noah Liel-Cohen, MD Soroka University Medical Center

Responsible Party: Diacardio LTD
ClinicalTrials.gov Identifier: NCT01515267     History of Changes
Other Study ID Numbers: DIA100
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: January 24, 2012
Last Verified: January 2012

Keywords provided by Diacardio LTD:
EF
EDV
ESV
Biplane
Echocardiography