Not Yet RecruitingNot Applicable

Safety and Performance of Dafodil Heart Valves in Real-World Aortic and Mitral Valve Replacement

500 participantsStarted 2026-04-01

Plain-language summary

This study, called the EuroDafodil Registry, is being conducted to understand how safe and effective the Dafodil™ and Dafodil Neo™ Pericardial Bioprosthetic heart valves are when used in routine medical practice. The registry includes adult patients (18 years or older) who require surgical replacement of their aortic or mitral heart valve, either because their natural valve is severely diseased or because a previously implanted valve is no longer working properly. All patients in this registry will receive a Dafodil™ heart valve as part of their standard surgical treatment. No experimental procedures are involved beyond usual clinical care. This is a prospective, multi-centre registry being conducted at approximately 50 hospitals across Europe, with a planned enrollment of at least 500 patients. The study does not compare treatments; instead, it follows patients who receive the Dafodil™ valve to collect real-world information on outcomes. Doctors will monitor patients during their hospital stay and through regular follow-up visits at 1 or 3 months, 1 year, 3 years, and up to 5 years after surgery. Information collected includes survival, heart valve function, complications such as blood clots or infections, heart performance on echocardiography, and quality of life. Participation in this registry is voluntary. All patients must provide written informed consent before joining. Patient privacy will be protected: personal identifiers will not be shared, and data will be coded so individuals cannot be directly identified. The results of this registry will help doctors and health authorities better understand the long-term safety, performance, and durability of the Dafodil™ heart valves in real-world clinical use.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Mortality, Thromboembolism, Valve Thrombosis, Paravalvular Leak, and Endocarditis

Timeframe: 1 year

Trial details

NCT IDNCT07379112

SponsorMeril Life Sciences Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-02

View on ClinicalTrials.gov More Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction trials