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

Egyptian Biomedical Research Network

Status: Completed

Conditions: Atrial Septal Defect (ASD)

Treatments: Procedure: modified transcatheter ASD closure; Procedure: Ordinary Transcatheter ASD closure

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT06655935

36264PR84/2/23

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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80 participants in 2 patient groups

44 patients with ASD who underwent the ordinary transcatheter closure technique using ASO.

Active Comparator group

Description:

The dilator of the Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over stiff wire into the pulmonary veins

Treatment:

Procedure: Ordinary Transcatheter ASD closure

36 patients with ASD who underwent the modified transcatheter closure technique using ASO

Experimental group

Description:

Amplatzer delivery sheath of the Amplatzer™ Septal Occluders ASO is advanced over the multipurpose catheter to the left atrial cavity

Treatment:

Procedure: modified transcatheter ASD closure