Echocardiography-guided Oval-shaped ASD Closure

NCT ID: NCT06526403

Last Updated: 2024-07-29

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-14

Study Completion Date

2023-05-30

Brief Summary

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Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.

Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.

Methods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

Detailed Description

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Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of its longest diameter. Research on the percutaneous closure of oval-shaped ASDs is limited, and to our knowledge, there are no reports of non-fluoroscopic closure for this specific population.

Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs.

Methods: This single-center, retrospective study examines patients undergoing percutaneous closure of oval-shaped ASDs using a non-fluoroscopy technique for initial decision-making. The device was selected to be approximately 0-4 mm larger than the longest diameter of the defect, based on measurements from transthoracic and transesophageal ultrasound.

Conditions

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ASD II Percutaneous Closure Zero-fluoroscopy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Zero-fluoroscopy oval-shaped secundum ASD closure
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Zero fluoroscopy oval-shaped secundum ASD closure

Group Type EXPERIMENTAL

Zero-fluoroscopy ASD closure

Intervention Type DEVICE

Percutaneous ASD closure without fluoroscopy was performed in secundum-type oval-shaped ASD

Interventions

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Zero-fluoroscopy ASD closure

Percutaneous ASD closure without fluoroscopy was performed in secundum-type oval-shaped ASD

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Oval-shaped secundum ASD with evidence of right ventricular overload, no significant and irreversible pulmonary arterial hypertension, no significant arrhythmia, no serious problems in other organs, and presumption of appropriate rims for device implantation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cardiovascular Center Harapan Kita Hospital Indonesia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cardiovascular Center Harapan Kita

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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LB.02.01/VII/020/KEP020/2023

Identifier Type: -

Identifier Source: org_study_id

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