Evaluating the Occlutech PDA Occluder for Patent Ductus Arteriosus
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
Occlutech International AB · NCT05264753
This study is testing if the Occlutech PDA Occluder is safe and effective for people with patent ductus arteriosus (PDA) after it has been implanted.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 255 (estimated) |
| Sex | All |
| Sponsor | Occlutech International AB (industry) |
| Locations | 15 sites (Montreal and 14 other locations) |
| Trial ID | NCT05264753 on ClinicalTrials.gov |
What this trial studies
This study is a multi-center, international, post-marketing follow-up that evaluates the safety and efficacy of the Occlutech PDA Occluder in patients with patent ductus arteriosus (PDA) defects. It involves both retrospective and prospective data collection, assessing vital signs, ECGs, and echocardiography at various time points after the device implantation. The study aims to enroll 255 subjects to ensure a robust analysis of the device's performance over time.
Who should consider this trial
Good fit: Ideal candidates include patients of any age who require non-surgical closure of patent ductus arteriosus and meet the inclusion criteria.
Not a fit: Patients with contraindications such as serious pulmonary hypertension, known coagulation disorders, or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective non-surgical option for closing patent ductus arteriosus defects in patients.
How similar studies have performed: Other studies have shown success with similar occlusion devices, indicating a promising approach for treating PDA defects.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal and 14 other locations
- 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, 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, 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, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Ahmed Dellaa, PhD
- Email: ahmed.dellaa@occlutech.com
- Phone: +49 3641 508 367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patent Ductus Arteriosus, Occlutech PDA Occluder, Patent ductus arteriosus closure, Transcatheter PDA occlusion, Percutaneous catheter-based intervention, Occluder device, Post-marketing clinical follow-up, PMCF