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| ID | Type | Description | Link |
|---|---|---|---|
| MLS/EURODAF-1 | Other Identifier | Meril Life Sciences Pvt. Ltd. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dafodil™ / Dafodil Neo™ Pericardial Bioprosthetic Heart Valve | Device | 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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|
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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