This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects with patent ductus arteriosus (PDA) defects. Safety and efficacy assessments include vital signs, electrocardiograms, and echocardiographic evaluations performed at baseline/implantation (including assessments within 36 hours post procedure), as well as at follow up visits occurring between Day 30 and Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation.
A subject 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. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects.
Male or female subjects.
Subjects or their parents/guardians understanding the nature of the study and providing their informed consent to participation.
Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP.
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
Full Analysis Set (safety): All patients intended to be treated with PDA Full Analysis Set (efficacy): All patients with implanted PDA
Other
Prospective
Occlutech® PDA Occluder
DeviceNon-surgical occlusion of Patent Ductus Arteriosus (PDA).
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.
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.
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.
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.
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