Comparative Analysis of Isolated Venous, Isolated Arterial, and Standard Access for Transcatheter Closure of Patent Ductus Arteriosus (PDA)

January 3, 2025 updated by: Nouran Mostafa Mansour, Egyptian Biomedical Research Network
We enrolled all patients with a hemodynamically significant PDA demonstrated by patient clinical condition, and by PDA size & left chamber dilatation on echocardiography attending at Cardiology Department to we compare the use of a single venous access and a single arterial access with the standard approach requiring both venous and arterial access for transcatheter PDA closure regarding the outcome & complications.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

357

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.

Study Locations

  • Egypt
      • Tanta, Egypt, 82005
        • Tanta University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • any patient with hemodynamically significant PDA

Exclusion Criteria:

  • patient with pulmonary hypertension and Eisenmenger syndrome

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 152 patients who underwent ordinary transcatheter closure technique using both arterial and venous a
Device: Transcatheter PDA closure
Transcatheter PDA closure
Active Comparator: 113 patients who underwent transcatheter closure using exclusive venous access only.
Device: Transcatheter PDA closure
Transcatheter PDA closure
Active Comparator: included 92 patients who underwent transcatheter closure using exclusive arterial access only.
Device: Transcatheter PDA closure
Transcatheter PDA closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
procedural and fluoroscopy time
Time Frame: during the procedure
during the procedure

Collaborators and Investigators

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

Sponsor

Egyptian Biomedical Research Network

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 (Actual)

January 1, 2020

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR897/10/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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