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

NCT ID: NCT04303793

Last Updated: 2020-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-06-30

Brief Summary

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

Detailed Description

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Conditions

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Congenital Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Percutaneous PDA closure

transcatheter patent ductus arteriosus closure

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Moheb El-Din

Assistant lecturer of cardiovascular medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ahmed Mohamed Moheb El-Din

Role: CONTACT

01060964666

Other Identifiers

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congenital heart disease

Identifier Type: -

Identifier Source: org_study_id

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