Viewing Study NCT06526403



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06526403
Status: COMPLETED
Last Update Posted: None
First Post: 2024-07-23

Brief Title: Echocardiography-guided Oval-shaped ASD Closure
Sponsor: None
Organization: None

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: No
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
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None