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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04303793
• Other study ID #: congenital heart disease
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 2022

Study information

• Verified date: March 2020
• Source: Assiut University
• Contact: Ahmed Mohamed Moheb El-Din
• Phone: 01060964666
• Email: ahmedmoheb34567[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Intervention

Device:
• Percutaneous PDA closure
transcatheter patent ductus arteriosus closure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	one month
Primary	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 )	one month
Primary	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)	one month