Balloon Pulmonary Valvuloplasty in Pulmonary Valvular StenosisNCT05748431
The Outcome of Percutaneous Balloon Pulmonary Valvuloplasty in Pediatrics
An observational study of Balloon Pulmonary Valvuloplasty in Pulmonary Valvular Stenosis, run by Assiut University.
Trial summary
evaluation the outcome of percutaneous balloon pulmonary valvuloplasty in children with valvular pulmonary stenosis at the Pediatric Cardiology Unit. Read more about this study
- Who is it for?
- Ages 1 day to 6 years
- Conditions the study is for
- Balloon Pulmonary Valvuloplasty in Pulmonary Valvular Stenosis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2023to Sep 2023
- 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 day to 6 years
- All sexes
- Child
Study population: Pediatric Cardiology Unit, Children and Cardiology Assiut University Hospitals
Who may be able to join
- Children with valvular pulmonary stenosis confirmed by Echocardiography, and managed with percutaneous balloon pulmonary valvuloplasty
Who cannot join
- Cases with pulmonary stenosis not candidate for balloon valvuloplasty Cases with pulmonary stenosis associated with other congenital heart diseases
Trial locations and contacts
No sites are listed yet.
About this study
evaluation the outcome of percutaneous balloon pulmonary valvuloplasty in children with valvular pulmonary stenosis at the Pediatric Cardiology Unit.
Read the detailed description
Pulmonary valve stenosis (PS) is a heart valve disorder in which outflow of blood from the right ventricle of the heart is obstructed at the level of the pulmonic valve. Although most commonly diagnosed and treated in the pediatric population, individuals with more severe forms of PS are surviving into adulthood and require ongoing assessment and cardiovascular care. The prevalence of valvular pulmonary stenosis has been reported at 0.6 to 0.8 cases per 1000 live births. When associated with other congenital heart disorder, it occurs in approximately 50% of all born with some kind of congenital heart disease . Pulmonary stenosis can be due to isolated valvular (90%), subvalvular, or peripheral (supravalvular) obstruction, or it may be found in association with congenital heart disorders of some other kind .
Critical pulmonary stenosis (PS) is a life-threatening congenital heart disease which requires immediate treatment . Unlike older children with isolated PS, neonates with critical PS presents with severe cyanosis and the suprasystemic right ventricle (RV) pressure may result in RV dilatation and failure with severe tricuspid regurgitation (TR). Since the discovery of balloon pulmonary valvuloplasty (BPV), it has replaced surgical approach for relieving PS . Femoral vein is the most common venous access for BPV; however, crossing the pulmonary valve using this approach can be difficult, especially in the presence of severe TR and right chambers dilatation . This problem can be overcome by using transjugular approach, yet many operators are reluctant to use this method because of potential complications and lack of data reporting transjugular approach. Balloon pulmonary valvuloplasty (BPV) is a safe and effective treatment for isolated pulmonary valve stenosis . The optimal age or body size for elective BPV depends on an individual's pulmonary valve diameter, transpulmonary pressure gradient, and femoral vessel size. Selecting a balloon with an appropriate profile also affects outcomes. An ideal balloon catheter for BPV in younger, smaller patients would have a low profile with a short, round shoulder to lessen the risk of valvular or vascular injury . Balloon pulmonary valvuloplasty provides long-term relief of stenosis of the pulmonary valve in the majority of patients with moderate to severe pulmonary valve stenosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the outcome of percutaneous ballon pulmonary valvuloplasty in children with pulmonary valvular stenosis at the pediatric cardiology unit
Evaluation depend on Echocariography measurement of pressure gradient pre and post valvuloplasty for about 100 cases of children up to 6 years in the pediatric cardiology y
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study startMar 2023 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balloon Pulmonary Valvuloplasty in Pulmonary Valvular StenosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Tarek Mohammed Hafez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748431
- Sponsor's protocol ID
- 75
- Status last verified
- Feb 2023
- First submitted
- 23 Aug 2022
- Last updated
- 28 Feb 2023
- 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 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome of Percutaneous Balloon Pulmonary Valvuloplasty in Pediatrics
- ClinicalTrials.gov ID
- NCT05748431
- Acronym / sponsor ID
- 75
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Mar 2023 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 28 Feb 2023 (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.
evaluation the outcome of percutaneous balloon pulmonary valvuloplasty in children with valvular pulmonary stenosis at the Pediatric Cardiology Unit.
Detailed description
Pulmonary valve stenosis (PS) is a heart valve disorder in which outflow of blood from the right ventricle of the heart is obstructed at the level of the pulmonic valve. Although most commonly diagnosed and treated in the pediatric population, individuals with more severe forms of PS are surviving into adulthood and require ongoing assessment and cardiovascular care. The prevalence of valvular pulmonary stenosis has been reported at 0.6 to 0.8 cases per 1000 live births. When associated with other congenital heart disorder, it occurs in approximately 50% of all born with some kind of congenital heart disease . Pulmonary stenosis can be due to isolated valvular (90%), subvalvular, or peripheral (supravalvular) obstruction, or it may be found in association with congenital heart disorders of some other kind .
Critical pulmonary stenosis (PS) is a life-threatening congenital heart disease which requires immediate treatment . Unlike older children with isolated PS, neonates with critical PS presents with severe cyanosis and the suprasystemic right ventricle (RV) pressure may result in RV dilatation and failure with severe tricuspid regurgitation (TR). Since the discovery of balloon pulmonary valvuloplasty (BPV), it has replaced surgical approach for relieving PS . Femoral vein is the most common venous access for BPV; however, crossing the pulmonary valve using this approach can be difficult, especially in the presence of severe TR and right chambers dilatation . This problem can be overcome by using transjugular approach, yet many operators are reluctant to use this method because of potential complications and lack of data reporting transjugular approach. Balloon pulmonary valvuloplasty (BPV) is a safe and effective treatment for isolated pulmonary valve stenosis . The optimal age or body size for elective BPV depends on an individual's pulmonary valve diameter, transpulmonary pressure gradient, and femoral vessel size. Selecting a balloon with an appropriate profile also affects outcomes. An ideal balloon catheter for BPV in younger, smaller patients would have a low profile with a short, round shoulder to lessen the risk of valvular or vascular injury . Balloon pulmonary valvuloplasty provides long-term relief of stenosis of the pulmonary valve in the majority of patients with moderate to severe pulmonary valve stenosis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- Pediatric Cardiology Unit, Children and Cardiology Assiut University Hospitals
Key inclusion criteria (1 listed)
- Children with valvular pulmonary stenosis confirmed by Echocardiography, and managed with percutaneous balloon pulmonary valvuloplasty
Key exclusion criteria (1 listed)
- Cases with pulmonary stenosis not candidate for balloon valvuloplasty Cases with pulmonary stenosis associated with other congenital heart diseases
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
To evaluate the outcome of percutaneous ballon pulmonary valvuloplasty in children with pulmonary valvular stenosis at the pediatric cardiology unit
Time frame: 3 years
Evaluation depend on Echocariography measurement of pressure gradient pre and post valvuloplasty for about 100 cases of children up to 6 years in the pediatric cardiology y
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Balloon Pulmonary Valvuloplasty in Pulmonary Valvular Stenosis, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Mohamed Hafez (+20 103 295 0691, eldoctor9995050@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the outcome of percutaneous ballon pulmonary valvuloplasty in children with pulmonary valvular stenosis at the pediatric cardiology unit (time frame: 3 years). 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 Feb 2023.