Status:
RECRUITING
PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
Lead Sponsor:
Occlutech International AB
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
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)...
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 A...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 25 2026
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT05264753
Start Date
December 20 2021
End Date
November 25 2026
Last Update
June 18 2023
Active Locations (8)
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1
Ospedale Pediatrico Bambin Gesù
Roma, Italy, 00146
2
Rawalpindi Institute of Cardiology
Rawalpindi, Pakistan
3
Military Hospital
Tunis, Tunisia
4
Aydın Adnan Menderes University Hospital
Aydin, Efeler, Turkey (Türkiye)