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

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.

NCT Number	NCT05264753
Lead Sponsor	Occlutech International AB
Conditions	Patent Ductus Arteriosus
Enrollment	255 participants
Start Date	2021-12-20
Primary Completion	2029-10-25 (estimated)
Study Completion	2029-11-25 (estimated)
Updated on ClinicalTrials.gov	2026-08-12