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

Not Applicable

• Conditions: Congenital Heart Disease

• Registration Number: NCT04303793
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-07
• Study First Submitted QC: 2020-03-09
• Last Update Submitted: 2020-03-09
• Study First Posted: 2020-03-11
• Last Update Posted: 2020-03-11
• Study Start: 2020-06-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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)