Condition: Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II) · Sponsor: Portuguese Association of Interventional Cardiology
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.
This description comes directly from the study's public registry record.
Rui C Teles, MD, PhD · (+351) 210 433 069 · rcteles@outlook.com
Joana D Silva, MD, PhD · secretariado.apic@spc.pt
Always discuss trial participation with your own doctor first.
| Hospitais da Universidade de Coimbra | Coimbra, Coimbra District, Portugal | Recruiting |
| Hospital da Luz Coimbra | Coimbra, Coimbra District, Portugal | Not Yet Recruiting |
| Hospital CUF Tejo | Lisbon, Lisbon District, Portugal | Recruiting |
| Hospital de Santa Cruz | Lisbon, Lisbon District, Portugal | Recruiting |
| Hospital Lusíadas Lisboa | Lisbon, Lisbon District, Portugal | Not Yet Recruiting |
| Hospital da Luz Lisboa | Lisbon, Lisbon District, Portugal | Not Yet Recruiting |
| Hospital Santa Maria | Lisbon, Lisbon District, Portugal | Recruiting |
| Hospital Santa Marta | Lisbon, Lisbon District, Portugal | Recruiting |
| Hospital Dr. Nélio Mendonça | Funchal, Madeira, Portugal | Not Yet Recruiting |
| Hospital Universitário de São João | Porto, Porto District, Portugal | Recruiting |
| Hospital Eduardo Santos Silva | Vila Nova de Gaia, Vila Nova de Gaia, Portugal | Not Yet Recruiting |
| Hospital do Espírito Santo de Évora | Evora, Évora District, Portugal | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07343674