Skip to main content
OpenTrials
Completed

NCT Number: NCT06526403

Echocardiography-guided Oval-shaped ASD Closure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ASD II Percutaneous Closure Zero-fluoroscopy

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cardiovascular Center Harapan Kita

Jakarta, 11420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zero-fluoroscopy ASD closure

Device

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

Primary outcomes

  1. Success rate

    Time frame: five years

Sponsors and collaborators

Lead sponsor

National Cardiovascular Center Harapan Kita Hospital Indonesia

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.