RecruitingNCT07343674

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

Enrollment

500 participants

Start Date

Jan 14, 2026

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with severe symptomatic aortic stenosis (defined as new york heart association (nyha) class ≥ ii). The study is currently recruiting participants at 12 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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NCT07343674