Patent Ductus ArteriosusNCT05264753
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
An observational study of Patent Ductus Arteriosus, run by Occlutech International AB at 15 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Occlutech® PDA Occluder
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 20 Dec 2021to 25 Nov 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Full Analysis Set (safety): All patients intended to be treated with PDA Full Analysis Set (efficacy): All patients with implanted PDA
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
15 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 9 countries
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Çukurova University Hospital
Adana, Sarıçam
Fadli Demir
Fadli Demir
- Recruiting
Aydın Adnan Menderes University Hospital
Aydin, Efeler
Serkan Fazlı Çelik
Serkan Fazlı Çelik
- Recruiting
Dicle University Hospital
Diyarbakır, SUR
Alper Akın
Alper Akın
- Recruiting
Eskişehir Osmangazi University Hospital
Eskişehir, Eskişehir, 26040
Birsen Uçar, Prof. Dr.
Birsen Uçar, Prof. Dr.
France3 sites, 3 recruiting
- Not yet recruiting
Hôpital Marie Lannelongue
Le Plessis-Robinson, Paris, 92350
Sebastien Hascoët, Dr
- Not yet recruiting
CHU de Lille - Institut Cœur-Poumon
Lille
François Godart
François Godart, Dr.
- Recruiting
Hôpital Mère Enfant, CHU de Nantes
Nantes
Alban Baruteau, MD, PhD, HDR, PU-PH
Alban Baruteau, Prof.Dr.
Tunisia2 sites, 2 recruiting
- Recruiting
Hospital La Rabta
Tunis
Abdeljelil Farhati
- Recruiting
Military Hospital
Tunis
Myriam Djait
Nahdem Hajlaoui, Dr.
Canada1 site, 1 recruiting
- Not yet recruiting
CHU Sainte-Justine
Montreal
Francisco Miguel Gonzalez Barlatay
Francisco Gonzalez, Dr.
Italy1 site, 1 recruiting
- Recruiting
Ospedale Pediatrico Bambino Gesù
Roma, Roma, 00146
Paolo Guccione, Prof. Dr.
Paolo Guccione, Prof. Dr.
Pakistan1 site, 1 recruiting
- Recruiting
Rawalpindi Institute of Cardiology
Rawalpindi, Rawalpindi
Hina Sattar, Dr.
Abdul Malik Sheikh, Prof.Dr.
Sweden1 site, 1 recruiting
- Recruiting
Children´s Hospital, Karolinska University
Stockholm
Petru Liuba, Dr
Switzerland1 site, 1 recruiting
- Not yet recruiting
Insel Gruppe
Bern
Kristoffer Steiner
Kristoffer Steiner
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Brompton & Harefield Hospitals
London, London, SW3 6NP
Alain Fraisse, Prof. Dr.
Alain Fraisse, Prof. Dr.
About this study
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
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.
Read the 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
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Occlutech® PDA Occluder
- 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
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlutech® PDA OccluderDevice
Non-surgical occlusion of Patent Ductus Arteriosus (PDA).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 years
Secondary outcomes (2)
Safety secondary endpoint
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.
Measured: 3 years
Efficacy secondary endpoint
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start20 Dec 2021
- Primary completion25 Oct 2029 (estimated)
- Study completion25 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 255 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Occlutech International AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264753
- Sponsor's protocol ID
- Occ2020_03
- Status last verified
- Jul 2026
- First submitted
- 13 Dec 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05264753
- Acronym / sponsor ID
- Occ2020_03
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Occlutech International ABIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 25 Oct 2029 (estimated)
- Study completion
- 25 Nov 2029 (estimated)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Full Analysis Set (safety): All patients intended to be treated with PDA Full Analysis Set (efficacy): All patients with implanted PDA
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlutech® PDA OccluderNon-surgical occlusion of Patent Ductus Arteriosus (PDA). | Device | – |
Primary outcome
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.
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 secondary outcomes
Safety secondary endpoint
Time frame: 3 years
Efficacy secondary endpoint
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Occlutech International AB at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Turkey (Türkiye), France, Tunisia, Canada, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Dellaa, PhD (+49 3641 508 367, ahmed.dellaa@occlutech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety primary endpoint (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.