Safety of AbsnowTM II Device for Closing Atrial Septal Defects
Part of Genetic & congenital, Heart & circulation clinical trials.
This trial tests a new absorbable device designed to close a hole in the wall between the heart's upper chambers (atrial septal defect or ASD). The device is placed through a catheter—a thin tube—without open-heart surgery, and may help prevent heart problems from the hole over time.
Summary written for real people, not researchers, by Clin2.
Who can take part
- Be at least 3 years old and weigh at least 10 kg (about 22 pounds)
- Have a secundum ASD (the most common type of atrial septal defect) with a hole between 5 mm and 26 mm in size
- Have enough healthy heart tissue around the ASD to safely place the device (specific distance measurements checked by echocardiogram)
- Be able to take aspirin or another blood-thinner medication for at least 6 months after the procedure
- Not be pregnant, breastfeeding, or planning pregnancy during the trial without contraception
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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