Congenital Heart DiseaseNCT04303793
Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
A study testing Percutaneous PDA closure in people with Congenital Heart Disease, run by Assiut University.
Trial summary
To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria. Read more about this study
- Who is it for?
- Ages 1 month to 70 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Percutaneous PDA closure
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to Jun 2022
- 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 1 month to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- all patients who are candidate for transcatheter PDA closure
Who cannot join
- Patients with PDA dependent pulmonary circulation.
- Patients with small sized PDA which is silent by auscultation
- Patients with large sized PDA which is unsuitable for Trans-catheter closure
- Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
- Patients with active infection or active infective endarteritis.
- Patients refusing the study.
Trial locations and contacts
No sites are listed yet.
About this study
To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.
- Conditions
- Congenital Heart Disease
- Being tested
- Percutaneous PDA closure
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous PDA closureDevice
transcatheter patent ductus arteriosus closure
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural safety
studying the occurrence of catheter related complications including
- Occurrence of vascular access hematoma(Yes/No )
- Occurrence of contrast induced nephropathy (Yes/No)
- PDA closure Device embolization (Yes/No)
- Cardiac tamponade (Yes/No)
Measured: one month
Procedural efficacy
timing of complete closure of the PDA with no residual shunts
- Residual left to right shunt (Yes/No)
- Degree of the residual shunt (Trace, Mild , Moderate, severe)
- Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural )
Measured: one month
Procedural outcomes
comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Moheb El-Din, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303793
- Sponsor's protocol ID
- congenital heart disease
- Status last verified
- Mar 2020
- First submitted
- 7 Mar 2020
- Last updated
- 11 Mar 2020
- 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 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.
- ClinicalTrials.gov ID
- NCT04303793
- Acronym / sponsor ID
- congenital heart disease
- Conditions
- Congenital Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 Mar 2020 (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.
To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 month to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all patients who are candidate for transcatheter PDA closure
Key exclusion criteria (6 listed)
- Patients with PDA dependent pulmonary circulation.
- Patients with small sized PDA which is silent by auscultation
- Patients with large sized PDA which is unsuitable for Trans-catheter closure
- Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7).
- Patients with active infection or active infective endarteritis.
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 |
|---|---|---|
| Percutaneous PDA closuretranscatheter patent ductus arteriosus closure | Device | – |
Primary outcome
Procedural safety
Time frame: one month
studying the occurrence of catheter related complications including 1. Occurrence of vascular access hematoma(Yes/No ) 2. Occurrence of contrast induced nephropathy (Yes/No) 3. PDA closure Device embolization (Yes/No) 4. Cardiac tamponade (Yes/No)
Procedural efficacy
Time frame: one month
timing of complete closure of the PDA with no residual shunts 1. Residual left to right shunt (Yes/No) 2. Degree of the residual shunt (Trace, Mild , Moderate, severe) 3. Timing of closure of the shunt( immediately postprocedural, 24 hours post procedural , 1 month post procedural )
Procedural outcomes
Time frame: one month
comparison of echocardiography data that will be done pre catheter closure, one day post procedure and one month later ( left ventricular and atrial dimensions-left ventricular ejection fraction-pulmonary artery systolic pressure- degree of tricuspid regurge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Related trials for Congenital Heart Disease
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
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 Percutaneous PDA closure in people with Congenital Heart Disease, 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 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: status not confirmed, as of the sponsor's last update on 11 Mar 2020. 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 Ahmed Mohamed Moheb El-Din (01060964666, ahmedmoheb34567@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural safety (time frame: one month). The study lists 3 primary outcomes in all. 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 11 Mar 2020.