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

Assiut University

Status: Unknown

Conditions: Congenital Heart Disease

Treatments: Device: Percutaneous PDA closure

Study type: Interventional

Funder types: Other

Identifiers

NCT04303793

congenital heart disease

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 1 month to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)