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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Disease, Mitral Valve Disease, Prosthetic Heart Valve Dysfunction; Valvular Heart Disease Requiring Surgical Aortic or Mitral Valve Replacement
• Intervention / Treatment: Device: Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve

• Study Type: Observational
• Enrollment (Estimated): 500

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Meril Life Sciences Pvt. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2033

Study Registration Dates

• First Submitted: January 23, 2026
• First Submitted That Met QC Criteria: January 23, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: January 31, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: MLS/EURODAF-1 (Other Identifier: Meril Life Sciences Pvt. Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No