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Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
Sponsor: Occlutech International AB
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.
Official title: 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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
255
Start Date
2021-12-20
Completion Date
2029-11-25
Last Updated
2026-01-27
Healthy Volunteers
No
Conditions
Interventions
Occlutech® PDA Occluder
Non-surgical occlusion of Patent Ductus Arteriosus (PDA).
Locations (15)
CHU Sainte-Justine
Montreal, Canada
CHU de Lille - Institut Cœur-Poumon
Lille, France
Hôpital Mère Enfant, CHU de Nantes
Nantes, France
Children's Hospital Ireland at Crumlin
Dublin, Ireland
Ospedale Pediatrico Bambino Gesù
Roma, Roma, Italy
Rawalpindi Institute of Cardiology
Rawalpindi, Rawalpindi, Pakistan
Children´s Hospital, Karolinska University
Stockholm, Sweden
Insel Gruppe
Bern, Switzerland
Hospital La Rabta
Tunis, Tunisia
Military Hospital
Tunis, Tunisia
Aydın Adnan Menderes University Hospital
Aydin, Efeler, Turkey (Türkiye)
Eskişehir Osmangazi University Hospital
Eskişehir, Eskişehir, Turkey (Türkiye)
Çukurova University Hospital
Adana, Sarıçam, Turkey (Türkiye)
Dicle University Hospital
Diyarbakır, SUR, Turkey (Türkiye)
Royal Brompton & Harefield Hospitals
London, London, United Kingdom