EF Evaluation From 4 Chamber PlaneLVivoEFNCT01515267
Automated Left Ventricular Function Evaluation by LVivoEF
An observational study of EF Evaluation From 4 Chamber Plane and EF Evaluation From 2 Chamber Plane, run by DiA Imaging Analysis Ltd at 1 site in Israel.
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)). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- EF Evaluation From 4 Chamber Plane, EF Evaluation From 2 Chamber Plane, Biplane EF Evaluation
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2011to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients referred to an echocardiographic examination
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- EF Evaluation From 4 Chamber Plane, EF Evaluation From 2 Chamber Plane, Biplane EF Evaluation, Left Ventricular Function
- Keywords
- EF, EDV, ESV, Biplane, Echocardiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2012 (estimated)
- Study startNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EF Evaluation From 4 Chamber PlaneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DiA Imaging Analysis Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noah Liel-Cohen, MD, Principal investigator, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515267
- Sponsor's protocol ID
- DIA100
- Acronym
- LVivoEF
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2012
- Last updated
- 24 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Left Ventricular Function Evaluation by LVivoEF
- ClinicalTrials.gov ID
- NCT01515267
- Acronym / sponsor ID
- LVivoEF / DIA100
- Conditions
- EF Evaluation From 4 Chamber Plane, EF Evaluation From 2 Chamber Plane, Biplane EF Evaluation, Left Ventricular Function
- Keywords
- EF, EDV, ESV, Biplane, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DiA Imaging Analysis LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- First posted
- 24 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients referred to an echocardiographic examination
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Liel-Cohen, MD principal investigator
Soroka University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of EF Evaluation From 4 Chamber Plane and EF Evaluation From 2 Chamber Plane, run by DiA Imaging Analysis Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2012; AzTrials last refreshed its copy on 26 Oct 2026.