Plain-English translation of NCT05655897 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 a new device called the GeminiOne Transcatheter Valve Edge-to-Edge Repair System, which repairs a leaky mitral valve (one of your heart's four valves) using a minimally invasive catheter procedure rather than open-heart surgery. The device works by gently clamping together the edges of the valve leaflets to reduce the backward flow of blood. This treatment is designed for patients with moderate-to-severe or severe mitral regurgitation who are at high risk for complications from traditional surgery.
Many patients with severely leaky mitral valves cannot safely undergo traditional open-heart surgery because of other health conditions or advanced age. This trial exists to provide an alternative treatment option that is less invasive and may be safer for high-risk patients who would otherwise have limited options.
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You would undergo a minimally invasive catheter procedure where doctors thread a thin tube through your blood vessels to reach your heart valve and deploy the GeminiOne repair device. The procedure typically involves insertion through the groin area, guided by imaging. You would need baseline heart imaging tests (echocardiograms) before the procedure and follow-up visits afterward to monitor how well the repair is working and check for any side effects. The study will enroll 120 patients across multiple medical centers.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
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