Plain-English translation of NCT04343313 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 early feasibility study is testing a new device called the Half Moon Transcatheter Mitral Valve Repair System, which is designed to fix a leaky mitral valve without open-heart surgery. The device is inserted through a blood vessel in the groin and guided to the heart, where it restores the valve's ability to close properly. This trial will enroll 30 patients with severe, symptomatic mitral regurgitation who are considered too high-risk for conventional valve surgery.
Many patients with severe leaky mitral valves cannot undergo traditional open-heart surgery because of other serious health conditions, yet their current medications alone are not controlling their symptoms. This trial exists to see if this new minimally invasive device can safely and effectively repair the valve for these high-risk patients who have limited options.
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Participants will undergo the Half Moon device implantation procedure, which involves a catheter inserted through the groin and guided to the heart to repair the leaky valve. The procedure itself is minimally invasive compared to open-heart surgery. After the procedure, you will have follow-up visits with your heart team to monitor your recovery, check how well the device is working, and watch for any side effects or complications. The exact duration of the study and number of follow-up visits will be discussed with you before enrollment.
AI-generated summary from trial data · Aug 9, 2026 · Not medical advice
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