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

March 9, 2020 updated by: Ahmed Mohamed Moheb El-Din, Assiut University

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

Study Overview

Status

Unknown

Conditions

Congenital Heart Disease

Intervention / Treatment

Device: Percutaneous PDA closure

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

all patients who are candidate for transcatheter PDA closure

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural safety Time Frame: one month	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
Procedural efficacy Time Frame: one month	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
Procedural outcomes Time Frame: 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)	one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2020

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

June 1, 2022

Study Registration Dates

First Submitted

March 7, 2020

First Submitted That Met QC Criteria

March 9, 2020

First Posted (Actual)

March 11, 2020

Study Record Updates

Last Update Posted (Actual)