Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occl… (NCT05264753) | Clinical Trial Compass
RecruitingNot Applicable
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
Canada, France, Italy255 participantsStarted 2021-12-20
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a post-marketing follow-up study rather than a traditional phase trial, does that mean the Occlutech PDA Occluder device is already approved for use, and what does that tell us about how much safety data already exists for it?
2How does my specific size and type of patent ductus arteriosus compare to the cases this device is designed to close, and am I a realistic candidate to discuss with the study team?
3What are the known risks of using the Occlutech occluder device specifically, and how do they compare to the risks of standard PDA closure options like surgery or other approved devices?
4Since the study is still recruiting, what does the follow-up schedule look like — how many visits would be required, over how long a period, and how would that fit into our current care plan?
5Would it be worth trying standard first-line PDA treatment before considering enrollment in this study, or is there a reason this trial might be worth discussing as a more immediate option given my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.