Plain-English translation of NCT05956652 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This is an observational study of the Hydra biological aortic valve prosthesis — a new device designed to replace a severely narrowed or failing aortic valve (the valve that controls blood flow out of your heart). Researchers will follow patients who receive this device to see how well it works and whether it's safe over time. The study will collect information from about 500 patients across different hospitals in Italy.
Severe aortic valve stenosis (narrowing) can be life-threatening, and some patients can't have traditional open-heart surgery. This registry was created to evaluate whether this new device is an effective and safe option for patients who need a valve replacement but have limited surgical choices.
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You will receive the Hydra valve implant through a catheter-based procedure (less invasive than open surgery). After your procedure, you'll be followed by the research team at regular clinic visits for up to 5 years. During these visits, doctors will check how well your new valve is working, assess your symptoms, and gather information about your overall health — all to track the device's long-term safety and effectiveness.
AI-generated summary from trial data · Jun 2, 2026 · Not medical advice
Italy
Sponsor
Sahajanand Medical Technologies Limited
Collaborators
Clinica Di Montevergine
Enrollment target
~500 participants
Started
July 2023
Primary completion
July 2027
Age range
18 Years – 99 Years
Last updated on clinicaltrials.gov in April 2026.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Dr. Angelo Cioppa
Montevergine Clinic, Mercogliano, Italy
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first — no email needed to get started.