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

January 24, 2026 updated by: Occlutech International AB

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Estimated)

255

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Montreal, Canada
        • Not yet recruiting
        • CHU Sainte-Justine
        • Contact:
        • Principal Investigator:
          • Francisco Gonzalez, Dr.
  • France
      • Lille, France
        • Not yet recruiting
        • CHU de Lille - Institut Cœur-Poumon
        • Contact:
          • François Godart
          • Phone Number: +33320445369
        • Principal Investigator:
          • François Godart, Dr.
      • Nantes, France
        • Recruiting
        • Hôpital Mère Enfant, CHU de Nantes
        • Contact:
        • Principal Investigator:
          • Alban Baruteau, Prof.Dr.
  • Ireland
      • Dublin, Ireland
        • Not yet recruiting
        • Children's Hospital Ireland at Crumlin
  • Italy
    • Roma
      • Roma, Roma, Italy, 00146
        • Recruiting
        • Ospedale Pediatrico Bambino Gesù
        • Contact:
        • Principal Investigator:
          • Paolo Guccione, Prof. Dr.
  • Pakistan
    • Rawalpindi
      • Rawalpindi, Rawalpindi, Pakistan
        • Recruiting
        • Rawalpindi Institute of Cardiology
        • Contact:
        • Principal Investigator:
          • Abdul Malik Sheikh, Prof.Dr.
  • Sweden
      • Stockholm, Sweden
        • Not yet recruiting
        • Children´s Hospital, Karolinska University
        • Contact:
        • Principal Investigator:
          • Kristoffer Jonathan Steiner, Dr.
  • Switzerland
      • Bern, Switzerland
        • Not yet recruiting
        • Insel Gruppe
        • Contact:
          • Kristoffer Steiner
        • Principal Investigator:
          • Kristoffer Steiner
  • Tunisia
      • Tunis, Tunisia
        • Recruiting
        • Military Hospital
        • Contact:
        • Principal Investigator:
          • Nahdem Hajlaoui, Dr.
        • Sub-Investigator:
          • Wafa Fehri, Dr.
        • Sub-Investigator:
          • Houaida Mahfoudhi, Dr.
      • Tunis, Tunisia
  • Turkey (Türkiye)
    • Efeler
      • Aydin, Efeler, Turkey (Türkiye)
        • Recruiting
        • Aydın Adnan Menderes University Hospital
        • Principal Investigator:
          • Serkan Fazlı Çelik
        • Contact:
    • Eskişehir
      • Eskişehir, Eskişehir, Turkey (Türkiye), 26040
        • Recruiting
        • Eskişehir Osmangazi University Hospital
        • Contact:
        • Principal Investigator:
          • Birsen Uçar, Prof. Dr.
        • Sub-Investigator:
          • Ahmet Sari, Prof. Dr.
    • SUR
      • Diyarbakır, SUR, Turkey (Türkiye)
        • Recruiting
        • Dicle University Hospital
        • Principal Investigator:
          • Alper Akın
        • Contact:
        • Sub-Investigator:
          • Mehmet Türe
    • Sarıçam
      • Adana, Sarıçam, Turkey (Türkiye)
        • Recruiting
        • Cukurova University Hospital
        • Contact:
        • Principal Investigator:
          • Fadli Demir
        • Sub-Investigator:
          • Nazan Özbarlas
  • United Kingdom
    • London
      • London, London, United Kingdom, SW3 6NP
        • Recruiting
        • Royal Brompton & Harefield Hospitals
        • Contact:
        • Principal Investigator:
          • Alain Fraisse, Prof. Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety primary endpoint
Time Frame: 1 year
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
Time Frame: 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety secondary endpoint
Time Frame: 3 years
Secondary safety endpoints will assess all minor complications such as transient hemolysis, vascular complications not requiring surgery, or all minor complications which are deemed relevant at the discretion of each investigator. Additionally, an assessment of all Serious Adverse Events (SAE) will be included in the analyses.
3 years
Efficacy secondary endpoint
Time Frame: 3 years
Secondary efficacy assessments refer to the variation in the data from baseline to 3 years after the procedure in parameters such as, but not limited to, aortic blood pressure, pulse rate, LVFS, pulmonary artery pressure, and ECG records.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Occlutech International AB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2021

Primary Completion (Estimated)

October 25, 2029

Study Completion (Estimated)

November 25, 2029

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 24, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Occ2020_03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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