Plain-English translation of NCT04433065 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 Intrepid TTVR System, a new device designed to replace a leaky tricuspid valve (one of the heart's four valves) without open-heart surgery. Instead of a traditional surgical approach, doctors thread the device through a blood vessel in the groin up to the heart, where it replaces the damaged valve. This treatment is being studied in people whose symptoms have not improved despite taking diuretics and other heart medications.
A severely leaky tricuspid valve can cause shortness of breath, swelling, and other serious symptoms, but traditional surgery to replace it carries significant risk for some patients. This trial exists to see if this new catheter-based procedure can safely and effectively treat these patients without the risks of open-heart surgery.
You likely qualify if…
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If you join this trial, you will undergo the minimally invasive catheter-based valve replacement procedure at one of the participating medical centers. After the procedure, you will be required to attend follow-up visits with your doctors to monitor how well the new valve is working and to check for any side effects. The trial is enrolling up to 150 patients and will track your progress over time to ensure the treatment is safe and effective.
AI-generated summary from trial data · Jun 5, 2026 · Not medical advice
United States