Plain-English translation of NCT05865119 on ClinicalTrials.gov ↗ ·
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This study is comparing two ways to treat a sinus venosus defect, a type of congenital heart condition where there is an opening in the wall between the heart's chambers. Researchers want to understand whether using a catheter-based approach with an OPTIMUS covered stent is just as safe and effective as traditional surgical repair. You would receive one of these two treatments based on what the research team determines is best for your specific situation.
Sinus venosus defects have traditionally been repaired with open-heart surgery, but newer catheter-based techniques using special stents may offer an alternative that avoids surgery. This trial will help doctors understand whether this newer, less invasive approach works as well as surgery and whether it should become a standard treatment option.
You likely qualify if…
You likely don't qualify if…
First, you'll have detailed imaging tests (CT and MRI scans) and heart function tests (including an exercise test and heart rhythm monitoring) to help the doctors understand your condition. A team of heart specialists will then meet to decide whether you're a candidate for the catheter-based approach or whether surgery would be better for you. If you're eligible and enrolled, you'll receive one of the two treatments and then be followed regularly to monitor how well it worked and whether you experience any side effects.
AI-generated summary from trial data · Jun 10, 2026 · Not medical advice
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