Follow-up study for a device that closes an abnormal heart blood vessel
Part of Genetic & congenital, Heart & circulation clinical trials.
This study checks how well and how safely the Occlutech PDA Occluder works over time to close a patent ductus arteriosus (PDA). You may be considered if your PDA can be treated with this non-surgical device and you can return for follow-up visits.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You have a PDA defect that the device is approved to treat based on the instructions for use
- You can have the device placed through a blood vessel (your body size is not limited as long as access is possible)
- You or your parent/guardian understands the study and agrees to join
- You’re able and willing to come back for scheduled follow-up visits and checks
- You do not have major heart-lung circulation problems listed in the instructions for use (like very high pressure or very high resistance in lung blood vessels)
- No blocking blood clot, recent heart infection, blood-clotting disorder, nickel/titanium allergy, contrast dye intolerance, or too-small blood vessels for the procedure
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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