Peri Membranous Ventricular Septal DefectNCT07623330
Use of TEE Derived Measurement vs Direct Measurement Under General Anesthesia in Assessment of Pressure Gradient in Peri Membranous Ventricular Septal Defect
An observational study of Peri Membranous Ventricular Septal Defect, run by Ain Shams University at 1 site in Egypt.
Trial summary
In this study, the investigators aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Peri Membranous Ventricular Septal Defect
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 27 May 2026to 20 Apr 2027
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: The study will include pediatric patients aged 6 months to 5 years diagnosed with isolated peri membranous ventricular septal defect (VSD) who are scheduled for elective surgical VSD closure under general anesthesia. All patients will undergo intraoperative assessment of the pressure gradient across the VSD using both transesophageal echocardiography (TEE)-derived measurements and direct intraoperative measurement techniques. Patients with other types of VSD, unrestrictive VSD, associated pulmonary vascular disease, recent or active upper respiratory tract infection, or any relative or absolute contraindication to TEE will be excluded. Informed consent will be obtained from legal guardians prior to enrollment.
Who may be able to join
- Pediatric patients (6 months to 5 years).
- Patients with isolated peri-membranous VSD.
- Scheduled for surgical VSD closure.
Who cannot join
- Refusal of legal guardians.
- Patients with other types of VSD.
- Patients with pulmonary vascular diseases.
- Patients with unrestrictive VSD.
- Recent or active upper respiratory tract infection.
- Any relative or absolute contraindication for TEE.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams
Cairo, Abbasia, 00202
karim mohammad el kersh, MBBCH, 01002123494, karim.elkersh@med.asu.edu.eg
About this study
In this study, the investigators aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient.
Read the detailed description
Ventricular septal defect is the most common congenital heart defect, occurring in 50% of all children with congenital heart disease (CHD) and in 20% as an isolated lesion.
The peri membranous (also called Para membranous or Cono ventricular) VSD is a communication adjacent to a portion of the membranous septum and the fibrous trigone of the heart, where the, and tricuspid valves are in fibrous continuity. These infracristal defects (below the crista supra- ventricularis) are the most common VSD subtype, accounting for approximately 80% of VSDs.
The ventricular septum can be well imaged by TEE. Starting from the standard transverse plane at 0° or so in the mi esophageal four-chamber (ME 4-Ch) view, the crux of the heart, the inlet septum and most of the muscular trabecular septum can be well seen from the AV valves down to the apex.
In this study, the investigators aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient.
During the pre-anesthetic evaluation, demographic variables will be collected from each patient. ASA physical status and relevant comorbidities will be documented, and a recent echocardiogram will confirm the presence of VSD, its size, pressure gradient and estimated PAP.
Patients will be taken to the operating room and monitored with ASA standard monitors: ECG, NIBP, pulse oximetry, and capnography. Preoxygenation will be performed with FiO₂ adjusted to maintain normal oxygen saturation Anesthesia inhalational induction will be performed with sevoflurane until IV access is secured. Once IV access is established, transition to IV agents, fentanyl (1-2 mcg/kg), and rocuronium (0.8 mg/kg). Ventilation with oxygen and sevoflurane 1.5% for 3 min.
Direct laryngoscopy and intubation will be performed by an attending anesthesiologist (with more than two years of experience post-qualification) along with femoral arterial and venous line along with internal jugular central venous line insertion.
Using the previously inserted lines, the pressure gradient across VSD along with RVSP and PASP are directly measured using catheters under guidance of fluoroscopy along with the hemodynamics it was obtained with. This entails that this should be performed in a hybrid theatre otherwise, the confirmation of catheter placement by TEE should be done. TEE inserted in the same setup under the same hemodynamics, RV inflow outflow view obtained with best alignment for CWD interrogation and pressure gradient obtained along with its respective hemodynamics, this step is to be repeated with different personnel with different levels of experience. Care should be taken that both measurements should be taken with the same hemodynamics. TEE measurements of pressure gradient across the VSD are to be measured in the ME five chamber view and ME aorta long axis view as well.
The surgeon will then perform median sternotomy, cpb cannulation, VSD repair. Any considerable events during weaning from cpb shall be recorded along with the doses needed for vasopressors and inotropic support. TEE post bypass will be done by senior attending confirming VSD closure, RV function and PAP if possible.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TEE derived measurement vs direct catheter measurement | Pediatric patients with isolated peri membranous VSD undergoing surgical closure will undergo intraoperative pressure gradient assessment using both TEE-derived and direct catheter-based measurements under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of TEE-derived pressure gradient measurement across peri membranous VSD
Accuracy of TEE derived Pressure gradient in numerical value across peri membranous VSD (in Rv inflow outflow view) in comparison with direct catheter-based measurements under general anesthesia.
Measured: intraoperative
Secondary outcomes (2)
Interrater agreement of TEE measurements
Assessment of agreement between different operators with different levels of experience regarding TEE image acquisition and TEE derived measurements.
Measured: intraoperative
Accuracy of TEE-derived RVSP and PASP measurements
Comparison between TEE-derived RVSP/PASP and direct catheter-based measurements under general anesthesia.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start27 May 2026 (estimated)
- Primary completion20 Jan 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri Membranous Ventricular Septal DefectStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623330
- Sponsor's protocol ID
- FMASU MD358/2025
- Status last verified
- May 2026
- First submitted
- 28 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of TEE Derived Measurement vs Direct Measurement Under General Anesthesia in Assessment of Pressure Gradient in Peri Membranous Ventricular Septal Defect
- ClinicalTrials.gov ID
- NCT07623330
- Acronym / sponsor ID
- FMASU MD358/2025
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 27 May 2026 (estimated)
- Primary completion
- 20 Jan 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 3 Jun 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.
In this study, the investigators aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient.
Detailed description
Ventricular septal defect is the most common congenital heart defect, occurring in 50% of all children with congenital heart disease (CHD) and in 20% as an isolated lesion.
The peri membranous (also called Para membranous or Cono ventricular) VSD is a communication adjacent to a portion of the membranous septum and the fibrous trigone of the heart, where the, and tricuspid valves are in fibrous continuity. These infracristal defects (below the crista supra- ventricularis) are the most common VSD subtype, accounting for approximately 80% of VSDs.
The ventricular septum can be well imaged by TEE. Starting from the standard transverse plane at 0° or so in the mi esophageal four-chamber (ME 4-Ch) view, the crux of the heart, the inlet septum and most of the muscular trabecular septum can be well seen from the AV valves down to the apex.
In this study, the investigators aim to compare the pressure gradient obtained by transesophageal echocardiography across the restrictive peri membranous VSD with direct catheter-based measurements of such gradient.
During the pre-anesthetic evaluation, demographic variables will be collected from each patient. ASA physical status and relevant comorbidities will be documented, and a recent echocardiogram will confirm the presence of VSD, its size, pressure gradient and estimated PAP.
Patients will be taken to the operating room and monitored with ASA standard monitors: ECG, NIBP, pulse oximetry, and capnography. Preoxygenation will be performed with FiO₂ adjusted to maintain normal oxygen saturation Anesthesia inhalational induction will be performed with sevoflurane until IV access is secured. Once IV access is established, transition to IV agents, fentanyl (1-2 mcg/kg), and rocuronium (0.8 mg/kg). Ventilation with oxygen and sevoflurane 1.5% for 3 min.
Direct laryngoscopy and intubation will be performed by an attending anesthesiologist (with more than two years of experience post-qualification) along with femoral arterial and venous line along with internal jugular central venous line insertion.
Using the previously inserted lines, the pressure gradient across VSD along with RVSP and PASP are directly measured using catheters under guidance of fluoroscopy along with the hemodynamics it was obtained with. This entails that this should be performed in a hybrid theatre otherwise, the confirmation of catheter placement by TEE should be done. TEE inserted in the same setup under the same hemodynamics, RV inflow outflow view obtained with best alignment for CWD interrogation and pressure gradient obtained along with its respective hemodynamics, this step is to be repeated with different personnel with different levels of experience. Care should be taken that both measurements should be taken with the same hemodynamics. TEE measurements of pressure gradient across the VSD are to be measured in the ME five chamber view and ME aorta long axis view as well.
The surgeon will then perform median sternotomy, cpb cannulation, VSD repair. Any considerable events during weaning from cpb shall be recorded along with the doses needed for vasopressors and inotropic support. TEE post bypass will be done by senior attending confirming VSD closure, RV function and PAP if possible.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEE derived measurement vs direct catheter measurement | – | –Pediatric patients with isolated peri membranous VSD undergoing surgical closure will undergo intraoperative pressure gradient assessment using both TEE-derived and direct catheter-based measurements under general anesthesia |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study will include pediatric patients aged 6 months to 5 years diagnosed with isolated peri membranous ventricular septal defect (VSD) who are scheduled for elective surgical VSD closure under general anesthesia. All patients will undergo intraoperative assessment of the pressure gradient across the VSD using both transesophageal echocardiography (TEE)-derived measurements and direct intraoperative measurement techniques. Patients with other types of VSD, unrestrictive VSD, associated pulmonary vascular disease, recent or active upper respiratory tract infection, or any relative or absolute contraindication to TEE will be excluded. Informed consent will be obtained from legal guardians prior to enrollment.
Key inclusion criteria (3 listed)
- Pediatric patients (6 months to 5 years).
- Patients with isolated peri-membranous VSD.
- Scheduled for surgical VSD closure.
Key exclusion criteria (6 listed)
- Refusal of legal guardians.
- Patients with other types of VSD.
- Patients with pulmonary vascular diseases.
- Patients with unrestrictive VSD.
- Recent or active upper respiratory tract infection.
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
Accuracy of TEE-derived pressure gradient measurement across peri membranous VSD
Time frame: intraoperative
Accuracy of TEE derived Pressure gradient in numerical value across peri membranous VSD (in Rv inflow outflow view) in comparison with direct catheter-based measurements under general anesthesia.
2 secondary outcomes
Interrater agreement of TEE measurements
Time frame: intraoperative
Accuracy of TEE-derived RVSP and PASP measurements
Time frame: intraoperative
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 22 Jun 2026.
- Individual participant dataSharing planned: Undecided
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 Peri Membranous Ventricular Septal Defect, run by Ain Shams University at 1 site in Egypt.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Jun 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 Egypt. 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 karim mohammad el kersh, MBBCH (01002123494, karim.elkersh@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of TEE-derived pressure gradient measurement across peri membranous VSD (time frame: intraoperative). 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 22 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.