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RECRUITING
NCT05264753

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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