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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 500
- Primary Endpoint
- Incidence of Mortality, Thromboembolism, Valve Thrombosis, Paravalvular Leak, and Endocarditis
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported