Plain-English translation of NCT06358391 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 whether a newer radiofrequency needle (the TS-RF Needle) works as well as or better than the standard mechanical needle currently used in Korea to access the left side of the heart during cardiac procedures. Both needles are used to create an opening in the heart wall, which allows doctors to treat conditions like atrial fibrillation (irregular heartbeats) and mitral stenosis (a narrowed heart valve). The study will compare how safely and effectively each needle performs this task.
Although radiofrequency needles have been used safely in other countries for over 20 years, Korea has only had access to older mechanical needles for this type of procedure. This trial will help determine whether patients in Korea could benefit from access to this newer technology.
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If you enroll, you will be randomly assigned to receive your heart procedure using either the new radiofrequency needle or the standard mechanical needle. The procedure itself—in which doctors access your left heart chamber to treat your condition—will proceed as normal. You will then be followed up and monitored to see how well each needle type worked and whether you experienced any side effects. The study involves about 70 patients total across multiple hospitals in Korea.
AI-generated summary from trial data · Jul 7, 2026 · Not medical advice
South Korea