PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Study Overview
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Brief Summary
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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 baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

Detailed Description
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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. 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). 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 occlude in subjects with patent ductus arteriosus defects. Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation. A sample size of N = 217 evaluable subjects will allow to estimate a proportion of ≤10% (or ≥90%) with precision of 4% at an alpha level of 5%. I.e., the total width of the two-sided 95%-confidence interval will be ≤8%. Accounting for an anticipated, maximum drop-out (e.g., patients being not evaluable for the primary endpoints due to missing follow-up) rate of 15%, a total number of 255 subjects needs to be enrolled. Besides, N=217 evaluable patients guarantee two-sided 95%-CIs for continuous variables' means having a width of  0.27 standard deviations (SD). This precision is sufficient for the descriptive objectives. 255 subjects treated for the non-surgical occlusion of PDA with the Occlutech® PDA Occluder. One should note that the majority (  90%) of the subjects will be children of young age (0-10 years). Study objectives To evaluate the safety of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus. To evaluate the efficacy of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.

Official Title
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A Multicenter, International, Prospective,Retrospective, PMCF Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects

Conditions
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Patent Ductus Arteriosus

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA). Exclusion Criteria: Contraindications as laid down in the IFU: Silent ductus or serious pulmonary hypertension: Pulmonary Vascular Resistance (PVR) > 8 Wood Units Presence of a known coagulation disorder Thrombus at the position allocated for the implantation A vein thrombosis in the blood vessels chosen for the introducing system An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure. Nitinol intolerance (nickel or titanium) Contrast medium intolerance Patients who have a vascular system (which is used to access the defect) that is too small to admit the required sheath
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety primary endpoint | The primary safety endpoint is defined as the incidence of any Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring surgery up to 1-year post-implantation. | 1 year | 
| Efficacy primary endpoint | The primary efficacy endpoint is defined as successful implantation of the Occlutech® PDA Occluder with a complete closure of the PDA (defined as >90% PDA closure represented by no or small residual flow) as assessed by echocardiography post-implantation) within 2-year post- implantation follow-up. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety secondary endpoint | Secondary safety endpoints will assess all minor complications such as transient hemolysis, vascular complications not requiring surgery, or all minor complications which are deemed relevant at the discretion of each investigator. Additionally, an assessment of all Serious Adverse Events (SAE) will be included in the analyses. | 3 years | 
| Efficacy secondary endpoint | Secondary efficacy assessments refer to the variation in the data from baseline to 3 years after the procedure in parameters such as, but not limited to, aortic blood pressure, pulse rate, LVFS, pulmonary artery pressure, and ECG records. | 3 years |