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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06655935
Enrollment
80
Registered
2024-10-24
Start date
2022-06-01
Completion date
2023-06-30
Last updated
2024-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Septal Defect (ASD)

Keywords

atrial septal defects, transcatheter closure, modified technique

Brief 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.

Detailed description

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

Interventions

PROCEDUREOrdinary 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

PROCEDUREmodified 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

Tanta University
CollaboratorOTHER
Egyptian Biomedical Research Network
Lead SponsorNETWORK

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
recording any complication during transcatheter secundum atrial septal defect closureduring the procedurestiff wire can cause perforation or arrhythmias

Secondary

MeasureTime frame
assess the duration of the procedure and if this affects the cost of the procedure by any meansduring the procedure

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026