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

NCT06655935 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-29

No results posted yet for this study

Summary

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.

Conditions

  • Atrial Septal Defect (ASD)

Interventions

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

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

Sponsors & Collaborators

  • Tanta University

    collaborator OTHER

  • Egyptian Biomedical Research Network

    lead NETWORK

Principal Investigators

  • Raghda El sheikh, professor · Cardiology departement-Tanta University hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2023-06-01
Completion
2023-06-30
FDA Device
Yes

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655935 on ClinicalTrials.gov