Patent Ductus Arteriosus Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 255 |
Est. completion date | November 25, 2026 |
Est. primary completion date | October 25, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale Pediatrico Bambin Gesù | Roma | |
Pakistan | Rawalpindi Institute of Cardiology | Rawalpindi | |
Tunisia | Military Hospital | Tunis | |
Turkey | Çukurova University Hospital | Adana | Sariçam |
Turkey | Aydin Adnan Menderes University Hospital | Aydin | Efeler |
Turkey | Dicle University Hospital | Diyarbakir | SUR |
Turkey | Eskisehir Osmangazi University Hospital | Eskisehir | |
United Kingdom | Royal Brompton & Harefield Hospitals | London |
Lead Sponsor | Collaborator |
---|---|
Occlutech International AB |
Italy, Pakistan, Tunisia, Turkey, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 |
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