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

NCT ID: NCT06655935

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-06-30

Brief Summary

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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

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

Conditions

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Atrial Septal Defect (ASD)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

Ordinary Transcatheter ASD closure

Intervention Type PROCEDURE

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

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

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

Group Type EXPERIMENTAL

modified transcatheter ASD closure

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role collaborator

Egyptian Biomedical Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Nouran Mostafa Mansour

dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Raghda El sheikh, professor

Role: STUDY_DIRECTOR

Cardiology departement-Tanta University hospital

Locations

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Tanta University

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR84/2/23

Identifier Type: -

Identifier Source: org_study_id

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