PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
NCT ID: NCT05264753
Last Updated: 2023-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
255 participants
OBSERVATIONAL
2021-12-20
2026-11-25
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
ALL
No
Sponsors
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Occlutech International AB
INDUSTRY
Responsible Party
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Locations
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Ospedale Pediatrico Bambin Gesù
Roma, , Italy
Rawalpindi Institute of Cardiology
Rawalpindi, , Pakistan
Military Hospital
Tunis, , Tunisia
Aydın Adnan Menderes University Hospital
Aydin, Efeler, Turkey (Türkiye)
Çukurova University Hospital
Adana, Sarıçam, Turkey (Türkiye)
Dicle University Hospital
Diyarbakır, SUR, Turkey (Türkiye)
Eskişehir Osmangazi University Hospital
Eskişehir, , Turkey (Türkiye)
Royal Brompton & Harefield Hospitals
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Occ2020_03
Identifier Type: -
Identifier Source: org_study_id
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