Plain-English translation of NCT06688448 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 two different biological (tissue-based) replacement heart valves — the Dafodil prosthesis and the INSPIRIS Resilia prosthesis — to see which one works better and lasts longer in patients who need aortic valve surgery. You would be randomly assigned to receive one of these two valves during your surgery, and doctors would follow you over time to see how well your new valve functions.
Aortic valve disease affects many people, and while surgical replacement with biological valves is an effective treatment, doctors want to know which newer valve designs perform best and stay healthy the longest in patients.
You likely qualify if…
You likely don't qualify if…
You would undergo aortic valve replacement surgery with one of the two study valves randomly assigned to you. After surgery, you would return for follow-up visits at the hospital where your heart function is monitored using imaging tests like echocardiograms and blood work. The trial team will track how well your new valve is working over time to compare the long-term durability and safety of the two devices.
AI-generated summary from trial data · Jun 22, 2026 · Not medical advice
Brazil
Sponsor
Instituto Dante Pazzanese de Cardiologia
Enrollment target
~200 participants
Started
December 2024
Primary completion
December 2026
Age range
18 Years – 65 Years
Last updated on clinicaltrials.gov in January 2025.
Reach out to the team running this trial. Response times vary — some teams are faster than others.
Central contact
Tacianne Rolemberg Delamain, Master Degree
Instituto Dante Pazzanese de Cardiologia
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.