A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.
Study Type
OBSERVATIONAL
Enrollment
150
Transcatheter Aortic Valve Implantation
Unidade Local de Saúde do Lisboa Ocidental E.P.E. - Hospital Santa Cruz
Carnaxide, Portugal
RECRUITINGUnidade Local de Saúde de Coimbra
Coimbra, Portugal
RECRUITINGUnidade Local de Saúde Alentejo Central E.P.E. - Hospital Espírito Santo
Evora, Portugal
Safety of Myval valve and TAVI procedure
Composite of: * All-cause mortality * All stroke * Acute kidney injury (stage 2, 3 and 4) * Bleeding (Type 3 and 4) * Moderate or severe paravalvular leak * Major vascular complications * Conduction disturbances resulting in new permanent pacemaker implantation
Time frame: 30 days
Safety and Performance of Myval valve and TAVI procedure
1. All-cause mortality (cardiac and non-cardiac) 2. All stroke 3. Acute Kidney Injury (AKI) System-Stage 2, 3 and 4 4. Moderate or severe paravalvular leak 5. Conduction disturbances and Arrythmias 6. New permanent pacemaker implantation 7. Major vascular complications 8. Vascular and access related complications 9. Echocardiography measurements 10. Procedure-related assessments 11. New York Heart Association (NYHA) Functional Classification 12. Re-Hospitalization 13. Bleeding (Type 3 and 4) 14. Myocardial Infarction 15. Length of index hospital stay 16. Cardiac structural complications 17. Aortic bioprosthetic valve dysfunction 18. Bioprosthetic valve deterioration 19. Conversion to open surgery 20. Unplanned use of mechanical circulatory support 21. Implantation of multiple (\>1) transcatheter valves during the index hospitalization 22. Valve malposition 23. Technical success 24. Device success 25. Early safety
Time frame: 30 days and 12 Months
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Unidade Local de Saúde de São José E.P.E. - Hospital Santa Marta
Lisbon, Portugal
NOT_YET_RECRUITINGUnidade Local de Saúde de Santa Maria, E.P.E. - Hospital de Santa Maria
Lisbon, Portugal
RECRUITINGUnidade Local de São João E.P.E.
Porto, Portugal
NOT_YET_RECRUITING