Plain-English translation of NCT05459233 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.
When a surgical heart valve fails, doctors can replace it using a minimally invasive procedure called valve-in-valve TAVR, which places a new valve (SAPIEN 3 ULTRA) inside the old one without open-heart surgery. This trial compares two different ways to check how well the new valve is working: using ultrasound imaging of the heart (called Doppler-echocardiography) versus a more invasive measurement taken directly from the heart using a catheter. The goal is to figure out which method helps doctors better optimize the valve's position and function.
After valve replacement, it's important to make sure the new valve is working as well as possible, but doctors aren't sure whether the quicker ultrasound method or the more detailed invasive method is better at guiding these adjustments during the procedure. This trial will help doctors understand which approach leads to better outcomes for patients.
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You will undergo the valve-in-valve TAVR procedure with the SAPIEN 3 ULTRA valve. During the procedure, you will be randomly assigned to one of two groups: one group will have their new valve checked and adjusted using ultrasound imaging of the heart, while the other group will have their valve checked and adjusted using more detailed pressure measurements taken directly from the heart. After the procedure, you'll have follow-up visits and imaging studies to monitor how well your new valve is working.
AI-generated summary from trial data · Jul 1, 2026 · Not medical advice
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