Plain-English translation of NCT04797572 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing a new surgical tool called the Free Margin Cusp Sizer, which helps surgeons measure the aortic valve leaflets during repair surgery. Instead of relying only on the surgeon's experience and visual judgment, this tool gives precise measurements in millimeters to guide the repair. The study will follow 120 patients to see if using this measurement tool makes the surgery safer and improves long-term outcomes.
Aortic valve repair surgery currently depends heavily on a surgeon's experience and visual estimation, which can be inconsistent and may limit success, especially for less experienced surgeons. This trial exists to see whether having an objective measurement tool during surgery can make repairs more reliable and reproducible, and improve results for all patients regardless of surgeon experience level.
You likely qualify if…
You likely don't qualify if…
If you join this trial, you will undergo aortic valve repair surgery at the hospital in Brussels, during which the surgeon will use the new Free Margin Cusp Sizer to measure your valve leaflets and guide the repair. You will stay in the hospital as you normally would after this type of surgery. After you go home, you will have follow-up heart ultrasounds (echocardiograms) at hospital discharge and again at 6 months to 1 year to check how well your valve is working.
AI-generated summary from trial data · Jun 10, 2026 · Not medical advice
Belgium