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

August 11, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
      • Montreal, Canada
        • Not yet recruiting
        • CHU Sainte-Justine
        • Principal Investigator:
          • Francisco Gonzalez, Dr.
        • Contact:
          • Francisco Miguel Gonzalez Barlatay
  • France
      • Lille, France
        • Not yet recruiting
        • CHU de Lille - Institut Cœur-Poumon
        • Contact:
          • François Godart
        • Principal Investigator:
          • François Godart, Dr.
      • Nantes, France
        • Recruiting
        • Hôpital Mère Enfant, CHU de Nantes
        • Principal Investigator:
          • Alban Baruteau, Prof.Dr.
        • Contact:
          • Alban Baruteau, MD, PhD, HDR, PU-PH
    • Paris
      • Le Plessis-Robinson, Paris, France, 92350
        • Not yet recruiting
        • Hôpital Marie Lannelongue
        • Contact:
          • Sebastien Hascoët, Dr
  • Italy
    • Roma
      • Roma, Roma, Italy, 00146
        • Recruiting
        • Ospedale Pediatrico Bambino Gesu
        • Principal Investigator:
          • Paolo Guccione, Prof. Dr.
        • Contact:
          • Paolo Guccione, Prof. Dr.
  • Pakistan
    • Rawalpindi
      • Rawalpindi, Rawalpindi, Pakistan
        • Recruiting
        • Rawalpindi Institute of Cardiology
        • Principal Investigator:
          • Abdul Malik Sheikh, Prof.Dr.
        • Contact:
          • Hina Sattar, Dr.
  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Children´s Hospital, Karolinska University
        • Contact:
          • Petru Liuba, Dr
  • Switzerland
      • Bern, Switzerland
        • Not yet recruiting
        • Insel Gruppe
        • Contact:
          • Kristoffer Steiner
        • Principal Investigator:
          • Kristoffer Steiner
  • Tunisia
      • Tunis, Tunisia
        • Recruiting
        • Military Hospital
        • Principal Investigator:
          • Nahdem Hajlaoui, Dr.
        • Sub-Investigator:
          • Wafa Fehri, Dr.
        • Sub-Investigator:
          • Houaida Mahfoudhi, Dr.
        • Contact:
          • Myriam Djait
      • Tunis, Tunisia
        • Recruiting
        • Hospital La Rabta
        • Contact:
          • Abdeljelil Farhati
  • Turkey (Türkiye)
    • Efeler
      • Aydin, Efeler, Turkey (Türkiye)
        • Recruiting
        • Aydın Adnan Menderes University Hospital
        • Principal Investigator:
          • Serkan Fazlı Çelik
        • Contact:
          • Serkan Fazlı Çelik
    • Eskişehir
      • Eskişehir, Eskişehir, Turkey (Türkiye), 26040
        • Recruiting
        • Eskişehir Osmangazi University Hospital
        • Principal Investigator:
          • Birsen Uçar, Prof. Dr.
        • Sub-Investigator:
          • Ahmet Sari, Prof. Dr.
        • Contact:
          • Birsen Uçar, Prof. Dr.
    • SUR
      • Diyarbakır, SUR, Turkey (Türkiye)
        • Recruiting
        • Dicle University Hospital
        • Principal Investigator:
          • Alper Akın
        • Sub-Investigator:
          • Mehmet Türe
        • Contact:
          • Alper Akın
    • Sarıçam
      • Adana, Sarıçam, Turkey (Türkiye)
        • Recruiting
        • Çukurova University Hospital
        • Principal Investigator:
          • Fadli Demir
        • Sub-Investigator:
          • Nazan Özbarlas
        • Contact:
          • Fadli Demir
  • United Kingdom
    • London
      • London, London, United Kingdom, SW3 6NP
        • Recruiting
        • Royal Brompton & Harefield Hospitals
        • Principal Investigator:
          • Alain Fraisse, Prof. Dr.
        • Contact:
          • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings