We Aim to Compare Modified Tricuspid Annular Plane Systolic Excursion With Tricuspid Annular Plane Systolic ExcursionTAPSENCT06221384
Transesophageal Echocardiography Transthoracic Echocardiography TAPSE
An observational study of We Aim to Compare Modified Tricuspid Annular Plane Systolic Excursion With Tricuspid Annular Plane Systolic Excursion, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Modified TAPSE (m-TAPSE) is a new method in which TAPSE is measured by taking the difference between the apical and lateral tricuspid annulus distance during diastole and systole. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- We Aim to Compare Modified Tricuspid Annular Plane Systolic Excursion With Tricuspid Annular Plane Systolic Excursion
- How many people
- 62 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 15 Jul 2026
- 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Transcatheterization procedures using TTE and TEE under anesthesia will be performed by pediatric cardiologist between the ages of 1-18.
Who may be able to join
- 1- Hastanın 1-18 yaş arasında olması 2- Pediyatrik kardiyak transkataterizasyon işlemi yapılması 3- ASA 1-3 hastalar
Who cannot join
- 1- Veli veya vasinin onay vermemesi 2- ASA 4 ve üzeri hastalar
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Modified Two-Dimensional and M-mode TAPSE With Transesophageal Echocardiography and M-mode TAPSE With Transthoracic Echocardiography in Pediatric Cardiac Transcatheter Interventions
Modified TAPSE (m-TAPSE) is a new method in which TAPSE is measured by taking the difference between the apical and lateral tricuspid annulus distance during diastole and systole. It can be measured using transesophageal echocardiography (TEE) in the mid-esophageal four-chamber (ME 4CH) view and is an alternative easily measurable parameter for intraoperative assessment of RV systolic function as long as optimal imaging quality is achieved.
In this prospective observational study, between 01.02.2024 and 15.07.2026, patients between the ages of 1-18 will undergo transcatheterization procedures using TTE and TEE under anesthesia by a pediatric cardiologist. TAPSE of these patients will be measured by TTE and TEE. TAPSE of the patients will be evaluated with TTE and TOE.
Read the detailed description
Modified TAPSE (m-TAPSE) is a new method in which TAPSE is measured by taking the difference between the apical and lateral tricuspid annulus distance during diastole and systole. It can be measured using transesophageal echocardiography (TEE) in the mid-esophageal four-chamber (ME 4CH) view and is an alternative easily measurable parameter for intraoperative assessment of RV systolic function as long as optimal imaging quality is achieved.
Our study will begin between 01.02.2024 and 15.07.2026 at Adnan Menderes University Practice and Research Hospital, after receiving the approval of the Ethics Committee of the patients. In this prospective observational study, it was planned to include all patients between the ages of 1 and 18 who underwent transcatheterization procedures using TTE and TEE under anesthesia by pediatric cardiologist. Written and verbal consent will be obtained from the parents/guardians of the patients. Patients will be anesthetized for transcatheter procedures and TAPSE and FAC values will be recorded during TTE and TEE echocardiography for the procedure. After the data collection process for the study is completed; The data will be compared statistically. TTE and TEE values of the patients will be compared among themselves.
All patients will undergo TEE and TTE under general anesthesia with an Echocardiography Device. The values of all parameters will be recorded by taking the average values of three cardiac cycle measurements. Measurement methods will be performed in accordance with the American Society of Echocardiography Guidelines. M-Mode, 2D images, color, pulse, Continuous Wave Doppler and Tissue Doppler measurements will be taken from all subjects complying with standard echocardiographic application methods. TAPSE will be calculated by placing an M-mode cursor across the Tricuspid Annulus and measuring the amount of longitudinal movement at peak systole.
m-TAPSE by TOE: m-TAPSE will be calculated as the 'difference between the apical to lateral tricuspid annular distance' during diastole and systole measured in the ME 4CH view. Within this cycle, the maximum and minimum dimensions will be obtained and the difference will be used to measure m-TAPSE. Longitudinal movement during systole will be measured by performing enhanced Doppler alignment with a modified transgastric RV inlet view and lower tricuspid annular motion.
End-diastolic area (EDA) and end-systolic area (ESA) are the FAC measurements that will be used in the TTE apical four-chamber view, while the same measurement will be made in the TEE four-chamber view, which also shows EDA and ESA.
- Keywords
- TAPSE, Modified TAPSE, Pediatric
What is being measured
The primary outcome is the main question the study is designed to answer.
echo
Intraoperatively, TAPSE and modified TAPSE values of patients will be measured.
Measured: 30 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Feb 2024
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for We Aim to Compare Modified Tricuspid Annular Plane Systolic Excursion With Tricuspid Annular Plane Systolic ExcursionStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ferdi gülaştı, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221384
- Sponsor's protocol ID
- 2024-1
- Acronym
- TAPSE
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Modified Two-Dimensional and M-mode TAPSE With Transesophageal Echocardiography and M-mode TAPSE With Transthoracic Echocardiography in Pediatric Cardiac Transcatheter Interventions
- ClinicalTrials.gov ID
- NCT06221384
- Acronym / sponsor ID
- TAPSE / 2024-1
- Keywords
- TAPSE, Modified TAPSE, Pediatric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 24 Jan 2024 (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.
Modified TAPSE (m-TAPSE) is a new method in which TAPSE is measured by taking the difference between the apical and lateral tricuspid annulus distance during diastole and systole. It can be measured using transesophageal echocardiography (TEE) in the mid-esophageal four-chamber (ME 4CH) view and is an alternative easily measurable parameter for intraoperative assessment of RV systolic function as long as optimal imaging quality is achieved.
In this prospective observational study, between 01.02.2024 and 15.07.2026, patients between the ages of 1-18 will undergo transcatheterization procedures using TTE and TEE under anesthesia by a pediatric cardiologist. TAPSE of these patients will be measured by TTE and TEE. TAPSE of the patients will be evaluated with TTE and TOE.
Detailed description
Modified TAPSE (m-TAPSE) is a new method in which TAPSE is measured by taking the difference between the apical and lateral tricuspid annulus distance during diastole and systole. It can be measured using transesophageal echocardiography (TEE) in the mid-esophageal four-chamber (ME 4CH) view and is an alternative easily measurable parameter for intraoperative assessment of RV systolic function as long as optimal imaging quality is achieved.
Our study will begin between 01.02.2024 and 15.07.2026 at Adnan Menderes University Practice and Research Hospital, after receiving the approval of the Ethics Committee of the patients. In this prospective observational study, it was planned to include all patients between the ages of 1 and 18 who underwent transcatheterization procedures using TTE and TEE under anesthesia by pediatric cardiologist. Written and verbal consent will be obtained from the parents/guardians of the patients. Patients will be anesthetized for transcatheter procedures and TAPSE and FAC values will be recorded during TTE and TEE echocardiography for the procedure. After the data collection process for the study is completed; The data will be compared statistically. TTE and TEE values of the patients will be compared among themselves.
All patients will undergo TEE and TTE under general anesthesia with an Echocardiography Device. The values of all parameters will be recorded by taking the average values of three cardiac cycle measurements. Measurement methods will be performed in accordance with the American Society of Echocardiography Guidelines. M-Mode, 2D images, color, pulse, Continuous Wave Doppler and Tissue Doppler measurements will be taken from all subjects complying with standard echocardiographic application methods. TAPSE will be calculated by placing an M-mode cursor across the Tricuspid Annulus and measuring the amount of longitudinal movement at peak systole.
m-TAPSE by TOE: m-TAPSE will be calculated as the 'difference between the apical to lateral tricuspid annular distance' during diastole and systole measured in the ME 4CH view. Within this cycle, the maximum and minimum dimensions will be obtained and the difference will be used to measure m-TAPSE. Longitudinal movement during systole will be measured by performing enhanced Doppler alignment with a modified transgastric RV inlet view and lower tricuspid annular motion.
End-diastolic area (EDA) and end-systolic area (ESA) are the FAC measurements that will be used in the TTE apical four-chamber view, while the same measurement will be made in the TEE four-chamber view, which also shows EDA and ESA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Transcatheterization procedures using TTE and TEE under anesthesia will be performed by pediatric cardiologist between the ages of 1-18.
Key inclusion criteria (1 listed)
- 1- Hastanın 1-18 yaş arasında olması 2- Pediyatrik kardiyak transkataterizasyon işlemi yapılması 3- ASA 1-3 hastalar
Key exclusion criteria (1 listed)
- 1- Veli veya vasinin onay vermemesi 2- ASA 4 ve üzeri hastalar
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
echo
Time frame: 30 minute
Intraoperatively, TAPSE and modified TAPSE values of patients will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 We Aim to Compare Modified Tricuspid Annular Plane Systolic Excursion With Tricuspid Annular Plane Systolic Excursion, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 28 Sep 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
echo (time frame: 30 minute). 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 28 Sep 2026.