NCT06526403

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 14, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
Last Updated

July 29, 2024

Status Verified

July 1, 2024

Enrollment Period

4.9 years

First QC Date

July 23, 2024

Last Update Submit

July 26, 2024

Conditions

ASD IIPercutaneous ClosureZero-fluoroscopy

Outcome Measures

Primary Outcomes (1)

  • Success rate

    five years

Study Arms (1)

Zero fluoroscopy oval-shaped secundum ASD closure

EXPERIMENTAL
Device: Zero-fluoroscopy ASD closure

Interventions

Zero-fluoroscopy ASD closureDEVICE

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

Zero fluoroscopy oval-shaped secundum ASD closure

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cardiovascular Center Harapan Kita

Jakarta, 11420, Indonesia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Zero-fluoroscopy oval-shaped secundum ASD closure
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2024

First Posted

July 29, 2024

Study Start

July 14, 2018

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

July 29, 2024

Record last verified: 2024-07

Locations

ID(1)