Actively Recruiting
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
Led by Occlutech International AB · Updated on 2026-01-27
255
Participants Needed
15
Research Sites
413 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A subject of any age eligible for PDA closure as described in the device's instructions for use, including those weighing more than 3 kg
- Male or female subjects
- Subjects or their parents/guardians understand the study and provide informed consent
- Subjects willing and able to attend all follow-up visits and procedures described in the study protocol
You will not qualify if you...
- Silent ductus or severe pulmonary hypertension with Pulmonary Vascular Resistance greater than 8 Wood Units
- Known blood clotting disorder
- Presence of a blood clot where the device will be implanted
- Vein thrombosis in blood vessels used for device insertion
- Active infection or history of endocarditis within 3 months before the procedure
- Intolerance to nickel or titanium (Nitinol intolerance)
- Intolerance to contrast medium
- Vascular system too small to allow insertion of the required sheath
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
CHU Sainte-Justine
Montreal, Canada
Not Yet Recruiting
2
CHU de Lille - Institut Cœur-Poumon
Lille, France
Not Yet Recruiting
3
Hôpital Mère Enfant, CHU de Nantes
Nantes, France
Actively Recruiting
4
Children's Hospital Ireland at Crumlin
Dublin, Ireland
Not Yet Recruiting
5
Ospedale Pediatrico Bambino Gesù
Roma, Roma, Italy, 00146
Actively Recruiting
6
Rawalpindi Institute of Cardiology
Rawalpindi, Rawalpindi, Pakistan
Actively Recruiting
7
Children´s Hospital, Karolinska University
Stockholm, Sweden
Not Yet Recruiting
8
Insel Gruppe
Bern, Switzerland
Not Yet Recruiting
9
Hospital La Rabta
Tunis, Tunisia
Actively Recruiting
10
Military Hospital
Tunis, Tunisia
Actively Recruiting
11
Aydın Adnan Menderes University Hospital
Aydin, Efeler, Turkey (Türkiye)
Actively Recruiting
12
Eskişehir Osmangazi University Hospital
Eskişehir, Eskişehir, Turkey (Türkiye), 26040
Actively Recruiting
13
Çukurova University Hospital
Adana, Sarıçam, Turkey (Türkiye)
Actively Recruiting
14
Dicle University Hospital
Diyarbakır, SUR, Turkey (Türkiye)
Actively Recruiting
15
Royal Brompton & Harefield Hospitals
London, London, United Kingdom, SW3 6NP
Actively Recruiting
Research Team
A
Ahmed Dellaa, PhD
CONTACT
G
Gonul Sonmez Utkun
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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