Plain-English translation of NCT06310031 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.
The INNOVATE Trial is testing whether a new heart pump device called the BrioVAD System works as well as an existing device called the HeartMate 3 for treating severe heart failure. Both devices are magnetically levitated pumps that help your heart pump blood when it can no longer do so on its own. This is the first head-to-head comparison of these two advanced pump technologies.
Some patients have heart failure so severe that standard medications and treatments don't help. This trial exists to see if the newer BrioVAD System is a safe and effective option compared to the established HeartMate 3 device, giving doctors another choice for patients who need a heart pump.
You likely qualify if…
You likely don't qualify if…
If you qualify and enroll, you will undergo surgery to have one of the two heart pump devices implanted in your chest. You'll be randomly assigned to receive either the BrioVAD System or the HeartMate 3 — you won't get to choose which one. After surgery, you'll attend regular follow-up visits so doctors can monitor how well the device is working, check your recovery, and watch for any side effects. The study involves about 780 patients across multiple hospital centers and will track your health over time.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
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