Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
A Multicenter, International, Prospective, Retrospective, Post Marketing Clinical Follow Up Study to Evaluate the Efficacy and Safety of the Occlutech Patent Ductus Arteriosus Occluder (PDA Occluder) in Patients With Patent Ductus Arteriosus Defects
Occlutech International AB
255 participants
Dec 20, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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.
Exclusion Criteria10
- 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
- Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath
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Interventions
Non-surgical occlusion of Patent Ductus Arteriosus (PDA).
Locations(15)
View Full Details on ClinicalTrials.gov
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NCT05264753