Plain-English translation of NCT04414878 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 the VitaFlow II Transcatheter Aortic Valve System, a new device that replaces a severely narrowed aortic valve without open-heart surgery. Instead of a large surgical incision, doctors insert this valve through a catheter (a thin tube) and guide it into place. The trial will enroll 145 patients at 18 medical centers in China to see whether this treatment is safe and works well for people with severe aortic stenosis.
Many older adults with severe aortic stenosis are too frail or have too many other health problems to survive traditional open-heart valve replacement surgery. This trial exists to test whether this new catheter-based valve system can safely help these high-risk patients without requiring major surgery.
You likely qualify if…
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If accepted, you will have the new heart valve implanted using a catheter procedure. After the implant, you will have follow-up visits at your hospital or by telephone at 30 days, 6 months, 12 months, and then yearly for 2 to 5 years. During these visits, doctors will check how well the new valve is working and monitor your overall health and symptoms.
AI-generated summary from trial data · Jun 28, 2026 · Not medical advice
China