Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve DysfunctionNCT07379112

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

An observational study of Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction and Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement, run by Meril Life Sciences Pvt. Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
What is being tested?: Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
Type of treatment: Medical device
How many people: 500 participants
Where: No sites listed yet
Study dates: 1 Apr 2026to 1 Dec 2033
How long will I take part?: 5 Years
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: 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.

Who may be able to join

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

Who cannot join

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

About this study

Official title: A Prospective, Multi-centre, Single-arm Registry to Evaluate the Safety and Performance of Dafodil™ Pericardial Bioprosthesis Series in Participants Undergoing Native/Prosthetic Aortic or Mitral Valve Replacement in Real World Settings

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.

Conditions: Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction, Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
Being tested: Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve
Medical subject headings: Aortic Valve Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart ValveDevice
The Dafodil™ and Dafodil Neo™ pericardial bioprosthetic heart valves are surgically implanted for replacement of a diseased or failed native or prosthetic aortic or mitral valve as part of standard clinical care. This observational registry prospectively follows participants to evaluate the safety and performance of the device in real-world clinical practice.

Study groups in NCT07379112
Study group	Role	What they receive
Patients undergoing surgical aortic or mitral valve replacement with the Dafodil™ or Dafodil Neo™ pe		Participants undergoing surgical replacement of a native or failed prosthetic aortic or mitral valve using the Dafodil™ or Dafodil Neo™ pericardial bioprosthetic heart valve. Participants are followed prospectively to assess safety and performance outcomes in real-world clinical practice. Receives: Device: Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Mortality, Thromboembolism, Valve Thrombosis, Paravalvular Leak, and Endocarditis
Composite of all-cause mortality, thromboembolism, valve thrombosis, major paravalvular leak, and endocarditis following surgical aortic or mitral valve replacement with a bioprosthetic heart valve.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 20261 Dec 2033

First posted30 Jan 2026
Study start1 Apr 2026 (estimated)
Primary completionFeb 2027 (estimated)
Study completion1 Dec 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 500 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT07379112
Sponsor's protocol ID: MLS/EURODAF-1
Other IDs: MLS/EURODAF-1
Status last verified: Jan 2026
First submitted: 23 Jan 2026
Last updated: 3 Feb 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No