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

NCT06655935 | Completed FDA Device

• 1 other identifier: 36264PR84/2/23
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Septal Defect (ASD)

Keywords

atrial septal defects; transcatheter closure; modified technique

Outcome Measures

Primary Outcomes (1)

• recording any complication during transcatheter secundum atrial septal defect closure

  stiff wire can cause perforation or arrhythmias

  during the procedure

Secondary Outcomes (1)

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

  during the procedure

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

EXPERIMENTAL

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

Interventions

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

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

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

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

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient with ostium secundum ASD \& RV volume overload

You may not qualify if:

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

Sponsors & Collaborators

• Egyptian Biomedical Research Network: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University

Tanta, 82005, Egypt

Location

MeSH Terms

Conditions

Heart Septal Defects, Atrial

Condition Hierarchy (Ancestors)

Heart Septal Defects; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Raghda El sheikh, professor

  Cardiology departement-Tanta University hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 24, 2024
• Study Start: June 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)