Indication The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) .Occlutech Occlusions-Pusher (OOP) and Occlutech Delivery Set (ODS) are recommended as delivery systems [13].~Study purpose This study aims to evaluate the safety and efficacy of The Occlutech PDA Occluder devices in patients with patent ductus arteriosus defects (PDA) by using Occlutech Occlusions-Pusher (OOP).~Study design This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA by using Occlutech Occlusions-Pusher (OOP) in patients with patent ductus arteriosus defects.~Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on Day 1 (within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years, and 4 to 5 years after implantation.~Sample size consideration A sample size of N = 100 patients is a pragmatic approach for such a study. It guarantees 95%-confidence intervals for binary variables with a maximal width (upper-lower limit) of 4.5% for rates=0% up to 10% (12.5%) for rates = 5% (10%). This statement is also valid for rates describing efficacy endpoints since the width of CI for a rate x is the same as for 100% - x (e. g. widths of CI for 90% and 10% rates are identical). Besides, this guarantees 95%-CIs for continuous variables' means having a width of ~0.4 standard deviations (SD). This precision is sufficient for the descriptive objectives.~Subject population 100 patients reated for the non-surgical occlusion of PDA with the Occlutech PDA Occluder. One should note that the majority (~ 90%) of the patients will be children of young age (0 -10years).~Study objectives To evaluate the efficacy of the Occlutech PDA Occluder by using Occlutech Occlusions-Pusher (OOP) in patients requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.~To evaluate the safety of the Occlutech PDA Occluder by using Occlutech Occlusions-Pusher (OOP) in patients requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.
This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA by using Occlutech Occlusions-Pusher (OOP) in patients with patent ductus arteriosus defects.~Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on Day 1 (within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years, and 4 to 5 years after implantation.