Plain-English translation of NCT03972644 on ClinicalTrials.gov โ ยท Source last updated ยท Translation generated ยท How we translate trials
This study doesn't follow the usual testing phases โ it may be an observational study or a different type of research.
This study is testing whether people with severe aortic stenosis (narrowing of the heart's aortic valve) who have no symptoms should have their valve replaced immediately or watched carefully over time. Half of participants will receive early valve replacement surgery or a catheter-based valve procedure, while the other half will be monitored with regular checkups and treated if symptoms appear. The goal is to find out which approach leads to better long-term health outcomes.
Doctors have long waited for symptoms to appear before replacing a stenotic aortic valve, but recent research suggests that early replacement โ before symptoms develop โ might prevent heart damage and improve survival. This large study aims to definitively answer whether operating early on carefully selected patients is safer and more effective than the traditional waiting approach.
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If you join this study, you will be randomly assigned to one of two groups. One group will have their aortic valve replaced promptly through either open-heart surgery or a minimally invasive catheter procedure. The other group will have regular heart checkups with imaging and blood tests, and will only have surgery if symptoms develop or certain warning signs appear on testing. Both groups will be followed for several years to compare long-term health outcomes, heart function, and quality of life.
AI-generated summary from trial data ยท Jun 5, 2026 ยท Not medical advice
Denmark
Sponsor
Odense University Hospital
Collaborators
Rigshospitalet, Denmark, Aarhus University Hospital
Enrollment target
~1,700 participants
Started
January 2020
Primary completion
September 2029
Age range
18 Years โ 85 Years
Last updated on clinicaltrials.gov in September 2020.
Reach out to the team running this trial. Response times vary โ some teams are faster than others.
Central contact
Jordi S Dahl, MD, PhD
Odense University Hospital
Tell us you're interested and we'll help connect you with the research team. We'll walk you through what to expect first โ no email needed to get started.