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

Meril Life Sciences

Status: Begins enrollment in 1 month

Conditions: Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction; Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement

Treatments: Device: Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve

Study type: Observational

Funder types: Industry

Identifiers

NCT07379112

MLS/EURODAF-1 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Patients undergoing surgical aortic or mitral valve replacement with the Dafodil™ or Dafodil Neo™ pe

Description:

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.

Treatment:

Device: Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve