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PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Sponsor: Portuguese Association of Interventional Cardiology
Summary
The goal of this registry is to learn how the Medtronic Evolut™ FX+ transcatheter aortic valve implantation (TAVI) System performs in adults with severe, symptomatic aortic stenosis who need valve replacement. The main questions it aims to answer are: * Can using a standardized procedure for the impantation of the Medtronic Evolut™ FX+ TAVI System increase safety and efficiency? * What are the short-term (30 days) and long-term (1 year) patient outcomes, including the need for a pacemaker, complications, and valve function? Participants will undergo TAVI with the Medtronic Evolut™ FX+ TAVI System as part of their routine care. Be followed during their hospital stay, at 30 days, and at 1 year to check heart health, valve function, and recovery. 500 people at 12 hospitals in Portugal will take part in this registry.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
500
Start Date
2026-01-14
Completion Date
2028-04
Last Updated
2026-04-08
Healthy Volunteers
No
Conditions
Locations (12)
Hospitais da Universidade de Coimbra
Coimbra, Coimbra District, Portugal
Hospital da Luz Coimbra
Coimbra, Coimbra District, Portugal
Hospital CUF Tejo
Lisbon, Lisbon District, Portugal
Hospital de Santa Cruz
Lisbon, Lisbon District, Portugal
Hospital Lusíadas Lisboa
Lisbon, Lisbon District, Portugal
Hospital da Luz Lisboa
Lisbon, Lisbon District, Portugal
Hospital Santa Maria
Lisbon, Lisbon District, Portugal
Hospital Santa Marta
Lisbon, Lisbon District, Portugal
Hospital Dr. Nélio Mendonça
Funchal, Madeira, Portugal
Hospital Universitário de São João
Porto, Porto District, Portugal
Hospital Eduardo Santos Silva
Vila Nova de Gaia, Vila Nova de Gaia, Portugal
Hospital do Espírito Santo de Évora
Evora, Évora District, Portugal