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
-
-
-
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
|
Transcatheter PDA closure
|
|
Active Comparator: 113 patients who underwent transcatheter closure using exclusive venous access only.
|
Transcatheter PDA closure
|
|
Active Comparator: included 92 patients who underwent transcatheter closure using exclusive arterial access only.
|
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.
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.