Patent Ductus Arteriosus (PDA)NCT06634407
Outcome of Transcatheter Closure of Patent Ductus Arteriosus in Pediatric Cardiology Unit in 3 Years Duration
A study testing transcatheter closure in people with Patent Ductus Arteriosus (PDA), run by Assiut University.
Trial summary
Transcatheter Closure of Patent Ductus Arteriosus to evaluate the outcome of percutaneous transcatheter closure of patent ductus arteriosus in children Read more about this study
- Who is it for?
- Ages 6 months to 16 years
- Conditions the study is for
- Patent Ductus Arteriosus (PDA)
- What is being tested?
- transcatheter closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2024to 15 Sep 2025
- Phase
- Interventional
- 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 6 months to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with Patent Ductus Arteriosus confirmed by echocardiography
- aged from 6 months to 16 years underwent percutaneous transcatheter PDA closure at Pediatric Cardiology Unit.
Who cannot join
- Children with PDA younger than 6 months or older than 16 years and that are not candidate for transcatheter closure .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transcatheter Closure of Patent Ductus Arteriosus. Experience of Pediatric Cardiology Unit-Assiut University Hospital
Transcatheter Closure of Patent Ductus Arteriosus to evaluate the outcome of percutaneous transcatheter closure of patent ductus arteriosus in children
- Conditions
- Patent Ductus Arteriosus (PDA)
- Being tested
- transcatheter closure
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcatheter closureProcedure or surgery
using transcatheter closure of PDA to detect outcome of patients with PDA
| Study group | Role | What they receive |
|---|---|---|
| PDA patients | Other | Not described Receives: Procedure: transcatheter closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
outcome of trancathter PDA closure
outcome of 90 patients with trancatheter PDA closure in pediatrics using post procedure catheter and echocardiography
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 posted9 Oct 2024
- Study start25 Oct 2024 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion15 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus Arteriosus (PDA)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassem Eldaba Hosny Fares, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634407
- Sponsor's protocol ID
- Transcatheter closure of PDA
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Closure of Patent Ductus Arteriosus. Experience of Pediatric Cardiology Unit-Assiut University Hospital
- ClinicalTrials.gov ID
- NCT06634407
- Acronym / sponsor ID
- Transcatheter closure of PDA
- Conditions
- Patent Ductus Arteriosus (PDA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 9 Oct 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.
Transcatheter Closure of Patent Ductus Arteriosus to evaluate the outcome of percutaneous transcatheter closure of patent ductus arteriosus in children
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDA patients | Other | Procedure: transcatheter closure |
Who may qualify
- Ages
- 6 months to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with Patent Ductus Arteriosus confirmed by echocardiography
- aged from 6 months to 16 years underwent percutaneous transcatheter PDA closure at Pediatric Cardiology Unit.
Key exclusion criteria (1 listed)
- Children with PDA younger than 6 months or older than 16 years and that are not candidate for transcatheter closure .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcatheter closureusing transcatheter closure of PDA to detect outcome of patients with PDA | Procedure or surgery | PDA patients |
Primary outcome
outcome of trancathter PDA closure
Time frame: 3 years
outcome of 90 patients with trancatheter PDA closure in pediatrics using post procedure catheter and echocardiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
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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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing transcatheter closure in people with Patent Ductus Arteriosus (PDA), 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 2 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 22 Oct 2024. 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 Bassem Eldaba Fares bassem fares (+201220851469, basam.13298661@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome of trancathter PDA closure (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 22 Oct 2024.