AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Recruitingn/aAges any - anyAllOcclutech International AB
💬

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 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 * Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath
💊

What it tests

  • Occlutech® PDA Occluder
📍

Where

15 sites
CHU Sainte-Justine
Montreal, Canada
Hôpital Marie Lannelongue
Le Plessis-Robinson, France
CHU de Lille - Institut Cœur-Poumon
Lille, France
Hôpital Mère Enfant, CHU de Nantes
Nantes, France
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Rawalpindi Institute of Cardiology
Rawalpindi, Pakistan
Children´s Hospital, Karolinska University
Stockholm, Sweden
Insel Gruppe
Bern, Switzerland

…and 7 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy