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Echocardiography-guided Oval-shaped ASD Closure

Echocardiography-Guided Percutaneous Closure of Oval-Shaped Secundum Atrial Septal Defects

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06526403
Enrollment
78
Registered
2024-07-29
Start date
2018-07-14
Completion date
2023-05-30
Last updated
2024-07-29

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

Conditions

ASD II, Percutaneous Closure, Zero-fluoroscopy

Brief summary

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

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.

Interventions

DEVICEZero-fluoroscopy ASD closure

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

Sponsors

National Cardiovascular Center Harapan Kita Hospital Indonesia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Zero-fluoroscopy oval-shaped secundum ASD closure

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Exclusion criteria

* Other than stated in inclusion criteria

Design outcomes

Primary

MeasureTime frame
Success ratefive years

Countries

Indonesia

Outcome results

None listed

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