Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-28 @ 5:58 AM
Study NCT ID:
NCT06526403
Status:
COMPLETED
Last Update Posted:
2024-07-29
First Post:
2024-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Echocardiography-guided Oval-shaped ASD Closure
Sponsor:
National Cardiovascular Center Harapan Kita Hospital Indonesia
Organization:
Study Overview
Official Title:
Echocardiography-Guided Percutaneous Closure of Oval-Shaped Secundum Atrial Septal Defects
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: