Plain-English translation of NCT06951672 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 AMEND Trans-Septal System, a new device designed to repair a leaky mitral valve (a common heart valve problem) without requiring traditional open-heart surgery. Instead of surgery, doctors will use a catheter—a thin tube—to deliver the device through your blood vessels and position it on the valve. The study will enroll up to 15 patients at centers in the U.S. and Canada to see if this treatment is safe and works well.
Many patients with a leaky mitral valve are too sick or frail to have traditional heart surgery. This trial exists to test whether this new minimally invasive device can offer these patients a safer option to repair their valve and improve their symptoms.
You likely qualify if…
You likely don't qualify if…
If you qualify, you will undergo the device implantation procedure, which involves the doctor inserting a catheter through a blood vessel in your groin and threading it to your heart valve. The procedure is done while you are under anesthesia. After implantation, you will return for follow-up visits and monitoring over 5 years to assess how well the device is working and whether you have any side effects or complications.
AI-generated summary from trial data · Jul 4, 2026 · Not medical advice
United States