NCT05264753

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 255 (estimated)
• Sponsor: Occlutech International AB · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The Occlutech® PDA Occluder is an occlusion system designed for the percutaneous, catheter based, non surgical closure of Patent Ductus Arteriosus (PDA), and is delivered using the Occlutech Occlusions Pusher (OOP) and Occlutech Delivery Set (ODS), which are recommended as compatible delivery systems. This post marketing clinical follow up study aims to evaluate the safety and efficacy of the Occlutech® PDA Occluder in subjects with PDA. The study is designed as a retrospective and prospective, multicenter, international investigation in which safety and efficacy will be assessed through vital signs, electrocardiography, and echocardiography at baseline/implantation (including assessments performed within 36 hours post procedure), followed by evaluations at Day 30 to Day 90, 6 months to 1 year, 1 to 2 years, and 2 to 3 years after implantation. A total of 217 evaluable subjects is required to estimate a proportion of ≤10% (or ≥90%) with a precision of 4% at an alpha level of 5%, corresponding to a two sided 95% confidence interval width of ≤8%. To account for an anticipated maximum drop out rate of 15%, a total of 255 subjects will be enrolled. Approximately 90% of enrolled participants are expected to be children aged 0-10 years. The primary objective of this study is to assess the safety of the Occlutech® PDA Occluder in subjects requiring transcatheter PDA closure, while the secondary objective is to evaluate the device's efficacy in achieving successful occlusion of the PDA

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DEVICE	Occlutech® PDA Occluder	Non-surgical occlusion of Patent Ductus Arteriosus (PDA).

Timeline

• Start date: 2021-12-20
• Primary completion: 2029-10-25
• Completion: 2029-11-25
• First posted: 2022-03-03
• Last updated: 2026-01-27

Locations

15 sites across 10 countries: Canada, France, Ireland, Italy, Pakistan, Sweden, Switzerland, Tunisia, Turkey (Türkiye), United Kingdom