Observational study of the AFR device for failing Fontan
Part of Genetic & congenital, Heart & circulation clinical trials.
This study looks at how well the Occlutech AFR device works for people with a failing Fontan circulation. It is only open to those who already received the device through a special early-access program.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must have already received the Occlutech AFR device through the special FDA early-access program.
- You (or your legal guardian) must have been told about the study and agreed to join, in writing, unless your hospital decided this wasn't needed.
- This study is only for people whose Fontan circulation is failing and who got the AFR device as part of that program.
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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