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

NCT05264753 | Recruiting

• 1 other identifier: Occ2020_03
• Study Type: observational
• Target: 255
• Locations: 9 countries
• Sites: 13

Brief 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.

Conditions

Patent Ductus Arteriosus

Keywords

Occlutech PDA Occluder; Patent ductus arteriosus closure; Transcatheter PDA occlusion; Percutaneous catheter-based intervention; Occluder device; Post-marketing clinical follow-up; PMCF; Prospective and retrospective study; Multicenter international study; Efficacy and safety; Echocardiography follow-up; Pediatric cardiology

Outcome Measures

Primary Outcomes (2)

• Safety primary endpoint

  The primary safety endpoint is defined as the incidence of any Serious Adverse Device Effects (SADEs) including procedure-related death, procedure-related stroke, systemic embolism, severe hemolysis, device embolization, cardiac tamponade, infective endocarditis, or vascular complications requiring surgery up to 1-year post-implantation.

  1 year

• Efficacy primary endpoint

  The primary efficacy endpoint is defined as successful implantation of the Occlutech® PDA Occluder with a complete closure of the PDA (defined as \>90% PDA closure represented by no or small residual flow) as assessed by echocardiography post-implantation) within 2-year post- implantation follow-up.

  2 years

Secondary Outcomes (2)

• Safety secondary endpoint

  3 years

• Efficacy secondary endpoint

  3 years

Interventions

Occlutech® PDA Occluder DEVICE

Non-surgical occlusion of Patent Ductus Arteriosus (PDA).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Full Analysis Set (safety): All patients intended to be treated with PDA Full Analysis Set (efficacy): All patients with implanted PDA

You may qualify if:

• A subject of any age will be eligible for PDA closure if he or she meets the indication and area of application as laid down in the IFU. Including subjects more than 3 kg. Thus, the Occlutech PDA Occluder is intended for the non-surgical occlusion of Patent Ductus Arteriosus (PDA) defects.
• Male or female subjects.
• Subjects or their parents/guardians understanding the nature of the study and providing their informed consent to participation.
• Subjects willing and able to attend the follow-up visits and procedures foreseen by study CIP.

You may not qualify if:

• Contraindications as laid down in the IFU:
• Silent ductus or serious pulmonary hypertension:
• Pulmonary Vascular Resistance (PVR) \> 8 Wood Units
• Presence of a known coagulation disorder
• Thrombus at the position allocated for the implantation
• A vein thrombosis in the blood vessels chosen for the introducing system
• An active infection (active endocarditis or other infections causing bacteremia) or history of endocarditis within 3 months from the procedure.
• Nitinol intolerance (nickel or titanium)
• Contrast medium intolerance
• Subjects who have a vascular system (which is used to access the defect) that is too small to admit the required sheath

Sponsors & Collaborators

• Occlutech International AB: lead

Study Sites (15)

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, 00146, 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, 26040, Turkey (Türkiye)

RECRUITING

Çukurova University Hospital

Adana, Sarıçam, Turkey (Türkiye)

RECRUITING

Dicle University Hospital

Diyarbakır, SUR, Turkey (Türkiye)

RECRUITING

Royal Brompton & Harefield Hospitals

London, London, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ahmed Dellaa, PhD

CONTACT

+49 3641 508 367; ahmed.dellaa@occlutech.com

Gonul Sonmez Utkun

CONTACT

+90 212 465 04 97; gonul.sonmezutkun@occlutech.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: March 3, 2022
• Study Start: December 20, 2021
• Primary Completion (Estimated): October 25, 2029
• Study Completion (Estimated): November 25, 2029
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

TU (4); GB (1); SE (1); PA (1); FR (2); CH (1); IT (1); CA (1); IE (1)