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Automated Left Ventricular Function Evaluation by LVivoEF

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Diacardio LTD
ClinicalTrials.gov Identifier:
NCT01515267
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Automated Left Ventricular Function Evaluation by LVivoEF

Further study details as provided by Diacardio LTD:

Estimated Enrollment: 100
Study Start Date: November 2011
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Diacardio LTD
ClinicalTrials.gov Identifier: NCT01515267     History of Changes
Other Study ID Numbers: DIA100
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Diacardio LTD:
EF
EDV
ESV
Biplane
Echocardiography

ClinicalTrials.gov processed this record on May 19, 2013