Procedural Outcomes of Percutaneous PDA Closure: Comparative Study Between Different Devices.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04303793

Enrollment

100

Registered

2020-03-11

Start date

2020-06-01

Completion date

2022-06-30

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Brief summary

To compare safety, efficacy and procedural outcome of percutaneous PDA closure using different approaches for better characterization of device selection criteria.

Interventions

DEVICEPercutaneous PDA closure

transcatheter patent ductus arteriosus closure

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 70 Years

Healthy volunteers

Inclusion criteria

* all patients who are candidate for transcatheter PDA closure

Exclusion criteria

1. Patients with PDA dependent pulmonary circulation. 2. Patients with small sized PDA which is silent by auscultation 3. Patients with large sized PDA which is unsuitable for Trans-catheter closure 4. Patients with PDA and severe irreversible pulmonary hypertension (Eisenmenger's syndrome) (7). 5. Patients with active infection or active infective endarteritis. 6. Patients refusing the study.

Design outcomes

Primary

Measure	Time frame	Description
Procedural safety	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	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	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)

Contacts

Primary ContactAhmed Mohamed Moheb El-Din

ahmedmoheb34567@gmail.com01060964666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026