Hemodynamically Significant PDANCT06763978
Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus (PDA)
A study testing Transcatheter PDA closure in people with Hemodynamically Significant PDA, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
We enrolled all patients with a hemodynamically significant PDA demonstrated by patient clinical condition, and by PDA size \& left chamber dilatation on echocardiography attending at Cardiology Department to we compare the use of a single venous access and a single arterial access with the standard approach requiring… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemodynamically Significant PDA
- What is being tested?
- Transcatheter PDA closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 31 Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- any patient with hemodynamically significant PDA
Who cannot join
- patient with pulmonary hypertension and Eisenmenger syndrome
Trial locations and contacts
1 site in 1 country.
About this study
We enrolled all patients with a hemodynamically significant PDA demonstrated by patient clinical condition, and by PDA size \& left chamber dilatation on echocardiography attending at Cardiology Department to we compare the use of a single venous access and a single arterial access with the standard approach requiring both venous and arterial access for transcatheter PDA closure regarding the outcome \& complications.
- Conditions
- Hemodynamically Significant PDA
- Being tested
- Transcatheter PDA closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter PDA closureDevice
Transcatheter PDA closure
| Study group | Role | What they receive |
|---|---|---|
| 152 patients who underwent ordinary transcatheter closure technique using both arterial and venous a | Active comparator | Not described Receives: Device: Transcatheter PDA closure |
| 113 patients who underwent transcatheter closure using exclusive venous access only. | Active comparator | Not described Receives: Device: Transcatheter PDA closure |
| included 92 patients who underwent transcatheter closure using exclusive arterial access only. | Active comparator | Not described Receives: Device: Transcatheter PDA closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
procedural and fluoroscopy time
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamically Significant PDAStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Nouran Mostafa Mansour, Egyptian Biomedical Research Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06763978
- Sponsor's protocol ID
- 36264PR897/10/24
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus (PDA)
- ClinicalTrials.gov ID
- NCT06763978
- Acronym / sponsor ID
- 36264PR897/10/24
- Conditions
- Hemodynamically Significant PDA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 8 Jan 2025 (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.
We enrolled all patients with a hemodynamically significant PDA demonstrated by patient clinical condition, and by PDA size \& left chamber dilatation on echocardiography attending at Cardiology Department to we compare the use of a single venous access and a single arterial access with the standard approach requiring both venous and arterial access for transcatheter PDA closure regarding the outcome \& complications.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 152 patients who underwent ordinary transcatheter closure technique using both arterial and venous a | Active comparator | Device: Transcatheter PDA closure |
| 113 patients who underwent transcatheter closure using exclusive venous access only. | Active comparator | Device: Transcatheter PDA closure |
| included 92 patients who underwent transcatheter closure using exclusive arterial access only. | Active comparator | Device: Transcatheter PDA closure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- any patient with hemodynamically significant PDA
Key exclusion criteria (1 listed)
- patient with pulmonary hypertension and Eisenmenger syndrome
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 PDA closureTranscatheter PDA closure | Device | 113 patients who underwent transcatheter closure using exclusive venous access only., 152 patients who underwent ordinary transcatheter closure technique using both arterial and venous a, included 92 patients who underwent transcatheter closure using exclusive arterial access only. |
Primary outcome
procedural and fluoroscopy time
Time frame: during the procedure
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 8 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Hemodynamically Significant PDA
Not yet recruitingObservational study
Research on the Individualized Treatment Strategy for Extremely Preterm Infants With hsPDA Based on Biomarkers and Targeted Delivery Systems
Hemodynamically Significant Patent Ductus Arteriosus
RecruitingObservational study
Relation Between Prostaglandin E2 Metabolite Levels and the Development of Hemodynamically Significant Patent Ductus Arteriosus in Preterm Neonates
Neonatal Prematurity, Patent Ductus Arteriosus in Preterm Infants
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?
A study testing Transcatheter PDA closure in people with Hemodynamically Significant PDA, run by Egyptian Biomedical Research Network 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 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 8 Jan 2025. 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?
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?
procedural and fluoroscopy time (time frame: during the procedure). 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 8 Jan 2025.