New heart valve registry aims to track safety in 500 patients across europe
NCT ID NCT07379112
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This registry will follow 500 adults who need surgical replacement of their aortic or mitral heart valve with a Dafodil bioprosthetic valve. The study collects real-world data on survival, valve function, and complications like blood clots or infection over 5 years. It aims to help doctors and regulators understand how well the valve performs in routine care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dafodil™ pericardial bioprosthetic heart valve (a surgically implanted device to replace a diseased or failed heart valve)
- What this could lead to
- If successful, this registry could confirm that the Dafodil valve is safe and works well in everyday medical practice, giving doctors more confidence to use it for patients needing valve replacement.
- What could go wrong
- This is an observational registry, not a controlled trial, so it cannot prove the valve is better than other options. Results depend on real-world conditions, and complications like blood clots or infection are possible with any heart valve surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2033
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Adult patients with advanced aortic or mitral valvular heart disease undergoing surgical replacement of a native or failed prosthetic valve with a bioprosthetic heart valve in routine clinical practice.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participant ≥18 years of age * Participants whose valvular disease is sufficiently advanced to warrant replacement of their natural/prosthetic aortic or mitral valve with Dafodil pericardial bioprosthesis series * Participants who are willing to undergo all protocol specific study procedures and follow-up requirements Exclusion Criteria: * Participants who are not willing to provide informed consent form, or whose legal heirs object to their participation in the registry * Participant with active endocarditis, active myocarditis or other systemic infection * Participants undergoing double valve replacement (DVR) * Any condition, which, in Investigator's opinion would preclude safe participation of participants in the registry
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Get notified about this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.