Novel Modified Technique for Transcatheter Closure of Secundum Atrial Septal Defect: A Single Center Experience

October 26, 2024 updated by: Nouran Mostafa Mansour, Egyptian Biomedical Research Network
Transcatheter closure of secundum atrial septal defects is widely approved worldwide, yet it still has multiple risks like perforation and radiation exposure. In this study, we proposed a modified rapid method for closure of secundum atrial septal defects, to avoid material manipulation inside your heart and decrease complication rate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Delivery sheath can be advanced over multipurpose catheter instead of stiff wire

Study Type

Interventional

Enrollment (Actual)

80

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 ostium secundum ASD & RV volume overload

Exclusion Criteria:

  • Any other type of atrial septal defects Any other associated congenital anomaly

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 44 patients with ASD who underwent the ordinary transcatheter closure technique using ASO.
The dilator of the Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over stiff wire into the pulmonary veins
Procedure: Ordinary Transcatheter ASD closure
deploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO inside the left atrial cavity over stiff wire into the pulmonary veins
Experimental: 36 patients with ASD who underwent the modified transcatheter closure technique using ASO
Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over the multipurpose catheter to the left atrial cavity
Procedure: modified transcatheter ASD closure
deploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO over the multipurpose catheter inside the left atrial cavity which might help in the shortage of the duration & the cost of the procedure with less complication rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recording any complication during transcatheter secundum atrial septal defect closure
Time Frame: during the procedure
stiff wire can cause perforation or arrhythmias
during the procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
assess the duration of the procedure and if this affects the cost of the procedure by any means
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

Collaborators

Tanta Medical School, Tanta University

Investigators

  • Study Director: Raghda El sheikh, professor, Cardiology departement-Tanta University hospital

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)

June 1, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

October 16, 2024

First Submitted That Met QC Criteria

October 22, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 26, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR84/2/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

because of the confidentiality of the patients data

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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