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OpenTrials
Completed

NCT Number: NCT06655935

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

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.

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Key information

Conditions

Atrial Septal Defect (ASD) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Atrial

Age range

3 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, 82005, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ordinary Transcatheter ASD closure

Procedure

deploying the Amplatzer delivery system of the Amplatzer™ Septal Occluders ASO inside the left atrial cavity over stiff wire into the pulmonary veins

modified transcatheter ASD closure

Procedure

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

Primary outcomes

  1. recording any complication during transcatheter secundum atrial septal defect closure

    Time frame: during the procedure

    stiff wire can cause perforation or arrhythmias

Secondary outcomes

  1. assess the duration of the procedure and if this affects the cost of the procedure by any means

    Time frame: during the procedure

Sponsors and collaborators

Lead sponsor

Egyptian Biomedical Research Network

Network

Collaborators

  • Tanta University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 24, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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