The objective of this PMCF study is to:
* confirm the safety and performance of the AcuMarkTM Sizing Balloon * identify previously unknown side-effects * monitor the identified side-effects (related to the procedure or to the medical devices)
Patients who have been confirmed with single secundum atrial septal defect (ASD) by echocardiography;
The anatomy of ASD is suitable for percutaneous closure;
Patients are scheduled to perform ASD closure;
Patients or legally authorized representative(s) who are willing and capable of providing informed consent.
Any contraindication for ASD closure;
Patients have ostium primum ASD or coronary sinus ASD;
Patients who are pregnant or breastfeeding;
Patient is currently participating in another clinical trial that has not yet completed its primary endpoint.
Patients with echocardiographic confirmation of a single secundum atrial septal defect (ASD) who are scheduled to undergo ASD closure.
Cohort
Prospective
Not listed
Sizing success rate
The size of the selected occluder is proper by echocardiography observing
Incidence of major adverse events (MAEs)
Major adverse events are defined as stroke, occluder embolization, arrhythmia, thromboembolic event, oversizing of the defect, cardiac tamponade, and other procedure and/or device-related complications requiring re-intervention.
Device success rate
Study device is successfully delivered in place and dilated without rupture and is successfully withdrew.
Incidence of procedure and/or device-related complications
Complications include vessel perforation/dissection, thromboembolism, hematoma, arrythmia, expansion of the defect, balloon migration, obstruction of venous return from the inferior vena cava.
Incidence of Serious Adverse Events
Incidence of Device Deficiency (DD)
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