Transesophageal EchocardiographyNCT07496424
Manual- VS Auto-Strain
An observational study of Transesophageal Echocardiography and Cardiac Anesthesia, run by Bruno Mora at 1 site in Austria.
Trial summary
Myocardial strain analysis provides additional and valuable information about left ventricular function, particularly in the perioperative setting with its dynamic changes in ventricular load conditions. This allows for earlier risk assessment and, if necessary, the initiation of faster and more targeted therapy. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Transesophageal Echocardiography, Cardiac Anesthesia, Cardiac Surgery Patients
- How many people
- 70 participants
- Where
- 1 siteAustria
- Study dates
- 23 Mar 2026to 23 Mar 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery who are monitored with a transesophageal echocardiography probe
Who may be able to join
- Adult (≥18 years) cardiac surgery patients
- Sinus rhythm
- No severe valvular regurgitation
- Use of General Electric (GE) echocardiography systems (Vivid S60, S70, E95) and corresponding EchoPAC software as well as TOMTEC software.
Who cannot join
- Inadequate image quality
- Any severe heart valve regurgitation
- Mechanical circulatory support systems (e.g., LVAD, Impella, ECMO)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
General Hospital of Vienna - Medical University of Vienna
Vienna, 1090
Bruno Mora, Dr, MD, PhD, +4314040041090, bruno.mora@meduniwien.ac.at
About this study
Official title: Automated Measurements of Left Ventricular Longitudinal Strain: Are the Results Comparable to Manual Measurements During Cardiac Surgery?
Myocardial strain analysis provides additional and valuable information about left ventricular function, particularly in the perioperative setting with its dynamic changes in ventricular load conditions. This allows for earlier risk assessment and, if necessary, the initiation of faster and more targeted therapy. Unfortunately, conventional strain analysis using conventional methods currently takes approximately 5 minutes. However, this amount of time is often not available in a dynamically changing intraoperative setting during cardiac surgery. Therefore, the benefits of strain analysis have not yet been routinely utilized during the intraoperative course. However, new software solutions exist that can perform strain analysis fully automatically and reduce the examination time to a few seconds. However, it remains unclear whether these fully automated analyses also function reliably intraoperatively using transesophageal echocardiography (TEE). The aim of this study is to assess the reliability of these new methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between conventionally measured global longitudinal strain (GLS) and fully automated global longitudinal strain (Auto-GLS)
Measured: 1-3 days
Secondary outcomes (1)
Correlation between fully automated global longitudinal strain measured using GE EchoPac (GE-Auto-GLS) and fully automated global longitudinal strain measured using TOMTEC AutoStrain (TOMTEC Auto-GLS)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start23 Mar 2026 (estimated)
- Primary completion23 Mar 2027 (estimated)
- Study completion23 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transesophageal EchocardiographyStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bruno Mora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bruno Mora, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07496424
- Sponsor's protocol ID
- MUV EK 2416/2025
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Measurements of Left Ventricular Longitudinal Strain: Are the Results Comparable to Manual Measurements During Cardiac Surgery?
- ClinicalTrials.gov ID
- NCT07496424
- Acronym / sponsor ID
- MUV EK 2416/2025
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Bruno MoraUniversity, hospital or other
- Study start
- 23 Mar 2026 (estimated)
- Primary completion
- 23 Mar 2027 (estimated)
- Study completion
- 23 Mar 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- 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.
Myocardial strain analysis provides additional and valuable information about left ventricular function, particularly in the perioperative setting with its dynamic changes in ventricular load conditions. This allows for earlier risk assessment and, if necessary, the initiation of faster and more targeted therapy. Unfortunately, conventional strain analysis using conventional methods currently takes approximately 5 minutes. However, this amount of time is often not available in a dynamically changing intraoperative setting during cardiac surgery. Therefore, the benefits of strain analysis have not yet been routinely utilized during the intraoperative course. However, new software solutions exist that can perform strain analysis fully automatically and reduce the examination time to a few seconds. However, it remains unclear whether these fully automated analyses also function reliably intraoperatively using transesophageal echocardiography (TEE). The aim of this study is to assess the reliability of these new methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery who are monitored with a transesophageal echocardiography probe
Key inclusion criteria (4 listed)
- Adult (≥18 years) cardiac surgery patients
- Sinus rhythm
- No severe valvular regurgitation
- Use of General Electric (GE) echocardiography systems (Vivid S60, S70, E95) and corresponding EchoPAC software as well as TOMTEC software.
Key exclusion criteria (3 listed)
- Inadequate image quality
- Any severe heart valve regurgitation
- Mechanical circulatory support systems (e.g., LVAD, Impella, ECMO)
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
Correlation between conventionally measured global longitudinal strain (GLS) and fully automated global longitudinal strain (Auto-GLS)
Time frame: 1-3 days
1 secondary outcome
Correlation between fully automated global longitudinal strain measured using GE EchoPac (GE-Auto-GLS) and fully automated global longitudinal strain measured using TOMTEC AutoStrain (TOMTEC Auto-GLS)
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No
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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.
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 Transesophageal Echocardiography and Cardiac Anesthesia, run by Bruno Mora at 1 site in Austria.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Mar 2026. 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Mora, Dr, MD, PhD (+4314040041090, bruno.mora@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between conventionally measured global longitudinal strain (GLS) and fully automated global longitudinal strain (Auto-GLS) (time frame: 1-3 days). It is what the study was designed to measure, not a finding.
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 27 Mar 2026.