A retrospective, single-arm, multicenter, observational, registry study to evaluate the safety and performance of Floret(TM) Atrial Septal Defect Occluder in a real-world setting.

Study Name: A retrospective, single-arm, multicenter, observational, registry study toevaluate the safety and performance of Floret™ Atrial Septal DefectOccluder in a real-world setting.

Short Title: Floret ASD Registry

Protocol ID,Version& Date:MLS/Floret ASD Registry -1_version 1.0.0_09-Jan-2025

Study Device: Floret™ Atrial Septal Defect Occluder

Indication: The Floret™ ASD Occluder is a percutaneous, transcatheter closure devicefor occlusion of the atrial septal defect in the secundum position or patientswho have undergone a fenestrated Fontan procedure, and who now have toclose the fenestration.Patients indicated for ASD closure have echocardiographic evidence ofostium secundum atrial septal defect or clinical evidence of RV volumeoverload. (i.e. 1.5:1 degree of left to right shunt or RV enlargement).

Objective: To evaluate the safety and performance of Floret™ Atrial Septal DefectOccluder.

Study Design: A retrospective, single-arm, multicenter, observational, registry study

Rationale of the studyThe Floret™ ASD Occluder is designed for the minimally invasive closure of atrial septaldefects (ASD) in the secundum position and for closing fenestrations in patients post-Fontanprocedure. While its clinical utility has been established, real-world data on its safety andperformance remain limited. This study aims to evaluate the device’s safety and effectiveness ina diverse, real-world population, addressing an important knowledge gap and providing insightsinto its performance in routine clinical practice.