PMCF Study to Evaluate Efficacy, Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects

Patent Ductus Arteriosus Clinical Trial

Official title: A Multicenter, International, Prospective,Retrospective, PMCF 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

Clinical Trial Summary

This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech PDA by using Occlutech Occlusions-Pusher (OOP) in patients with patent ductus arteriosus defects.

Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

Clinical Trial Description

Indication The Occlutech PDA Occluder is an occlusion system, which is percutaneously implanted through a catheter intervention technique and intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) .Occlutech Occlusions-Pusher (OOP) and Occlutech Delivery Set (ODS) are recommended as delivery systems.

Study purpose This study aims to evaluate the safety and efficacy of The Occlutech PDA Occluder devices in patients with patent ductus arteriosus defects (PDA).

Study design This is a retrospective and prospective, multi-center, international, post marketing follow-up study to evaluate the safety and efficacy of the Occlutech® PDA occlude in subjects with patent ductus arteriosus defects.

Efficacy and safety of implanted device(s) will be evaluated by vital signs, ECGs, and echocardiography data on baseline/implantation visit (include assessments within 36 hrs. post-procedure), Day 30 to Day 90, 6 months to 1 year, 2 years to 3 years after implantation.

A sample size of N = 217 evaluable subjects will allow to estimate a proportion of ≤10% (or ≥90%) with precision of 4% at an alpha level of 5%. I.e., the total width of the two-sided 95%-confidence interval will be ≤8%.

Accounting for an anticipated, maximum drop-out (e.g., patients being not evaluable for the primary endpoints due to missing follow-up) rate of 15%, a total number of 255 subjects needs to be enrolled. Besides, N=217 evaluable patients guarantee two-sided 95%-CIs for continuous variables' means having a width of ~0.27 standard deviations (SD). This precision is sufficient for the descriptive objectives.

255 subjects treated for the non-surgical occlusion of PDA with the Occlutech® PDA Occluder. One should note that the majority (~ 90%) of the subjects will be children of young age (0-10 years).

Study objectives To evaluate the safety of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus.

To evaluate the efficacy of the Occlutech® PDA Occluder in subjects requiring transcatheter occlusion (closure) of Patent Ductus Arteriosus. ;

Related Conditions & MeSH terms

• Ductus Arteriosus, Patent
• Patent Ductus Arteriosus

• NCT number: NCT05264753
• Study type: Observational [Patient Registry]
• Source: Occlutech International AB
• Contact: Hussa Al Othman
• Phone: +49 3641 508 365
• Email: hussa.alothman@occlutech.com
• Status: Recruiting
• Start date: December 20, 2021
• Completion date: November 25, 2026