PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- safety primary endpoint [1 year]
The primary safety endpoint is defined as the absence (y/n) 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 [1 year]
The primary efficacy endpoint is defined as successful implantation of The Occlutech PDA Occluder with Occlutech Occlusions-Pusher (OOP) with a complete closure of the PDA (defined as 95-100% PDA closure as assessed by echocardiography post-implantation) assessed at 1-year post-implantation Follow-Up.
Eligibility Criteria
Criteria
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:
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Contraindications as laid down in the IFU:
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Silent ductus or serious pulmonary hypertension:
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Pulmonary Vascular Resistance (PVR) > 8 Wood Units
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Presence of a known coagulation disorder
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Thrombus at the position allocated for the implantation
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A vein thrombosis in the blood vessels chosen for the introducing system
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An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure.
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Nitinol intolerance (nickel or titanium)
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Contrast medium intolerance
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Patients who have a vascular system (which is used to access the defect) that is too small to admit the required sheath
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aydın Adnan Menderes University Hospital | Aydın | Efeler | Turkey | |
| 2 | Çukurova University Hospital | Adana | Sarıçam | Turkey | |
| 3 | Dicle University Hospital | Diyarbakır | SUR | Turkey |
Sponsors and Collaborators
- Occlutech International AB
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Occ2020_03