NCT05264753 Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
| NCT ID | NCT05264753 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Occlutech International AB |
| Condition | Patent Ductus Arteriosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 255 participants |
| Start Date | 2021-12-20 |
| Primary Completion | 2029-10-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 255 participants in total. It began in 2021-12-20 with a primary completion date of 2029-10-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05264753 clinical trial?
This trial is open to participants of all sexes, studying Patent Ductus Arteriosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05264753 currently recruiting?
Yes, NCT05264753 is actively recruiting participants. Contact the research team at ahmed.dellaa@occlutech.com for enrollment information.
Where is the NCT05264753 trial being conducted?
This trial is being conducted at Montreal, Canada, Le Plessis-Robinson, France, Lille, France, Nantes, France and 11 additional locations.
Who is sponsoring the NCT05264753 clinical trial?
NCT05264753 is sponsored by Occlutech International AB. The trial plans to enroll 255 participants.