Condition: Patent Ductus Arteriosus · Sponsor: Occlutech International AB
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.
This description comes directly from the study's public registry record.
Ahmed Dellaa, PhD · +49 3641 508 367 · ahmed.dellaa@occlutech.com
Gonul Sonmez Utkun · +90 212 465 04 97 · gonul.sonmezutkun@occlutech.com
Always discuss trial participation with your own doctor first.
| CHU Sainte-Justine | Montreal, Canada | Not Yet Recruiting |
| CHU de Lille - Institut Cœur-Poumon | Lille, France | Not Yet Recruiting |
| Hôpital Mère Enfant, CHU de Nantes | Nantes, France | Recruiting |
| Children's Hospital Ireland at Crumlin | Dublin, Ireland | Not Yet Recruiting |
| Ospedale Pediatrico Bambino Gesù | Roma, Roma, Italy | Recruiting |
| Rawalpindi Institute of Cardiology | Rawalpindi, Rawalpindi, Pakistan | Recruiting |
| Children´s Hospital, Karolinska University | Stockholm, Sweden | Not Yet Recruiting |
| Insel Gruppe | Bern, Switzerland | Not Yet Recruiting |
| Hospital La Rabta | Tunis, Tunisia | Recruiting |
| Military Hospital | Tunis, Tunisia | Recruiting |
| Aydın Adnan Menderes University Hospital | Aydin, Efeler, Turkey (Türkiye) | Recruiting |
| Eskişehir Osmangazi University Hospital | Eskişehir, Eskişehir, Turkey (Türkiye) | Recruiting |
+ 3 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05264753