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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
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.
|
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
Time Frame: 1 year
|
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
Studies a U.S. FDA-regulated device product
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