PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI

Recruiting now

Conditions studied: Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)

In brief

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 facts

Study ID

NCT07343674

Run by

Portuguese Association of Interventional Cardiology

People needed

500

Starts

2026-01-14

Expected to finish

2028-04-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects more than 18 years old, able to provide an Informed Consent:
• Severe symptomatic (defined as New York Heart Association (NYHA) class ≥ II) aortic stenosis (AS), including but not limited to: Dyspnea at rest or on exertion, fatigue, angina, syncope in the absence of another identifiable cause;
• Subjects provided written Informed Consent as approved by the Ethics Committee (EC);

You may not qualify if…

• Subjects with pre-existing surgical bioprosthetic aortic valve;
• Hepatic insufficiency (Child-Pugh Class B or C);
• Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU);
• Anatomically considered not suitable for the Medtronic Evolut™ FX+ TAVI system;
• Subjects are currently participating in another clinical investigation that may confound the results of this Registry;
• Subjects have an expected survival less than one year.

Where it is running

• Hospitais da Universidade de Coimbra — Coimbra, Coimbra District, Portugal (enrolling)
• Hospital CUF Tejo — Lisbon, Lisbon District, Portugal (enrolling)
• Hospital de Santa Cruz — Lisbon, Lisbon District, Portugal (enrolling)
• Hospital Santa Maria — Lisbon, Lisbon District, Portugal (enrolling)
• Hospital Santa Marta — Lisbon, Lisbon District, Portugal (enrolling)
• Hospital Universitário de São João — Porto, Porto District, Portugal (enrolling)
• Hospital do Espírito Santo de Évora — Evora, Évora District, Portugal
• Hospital da Luz Coimbra — Coimbra, Coimbra District, Portugal
• Hospital Eduardo Santos Silva — Vila Nova de Gaia, Vila Nova de Gaia, Portugal
• Hospital Dr. Nélio Mendonça — Funchal, Madeira, Portugal
• Hospital Lusíadas Lisboa — Lisbon, Lisbon District, Portugal
• Hospital da Luz Lisboa — Lisbon, Lisbon District, Portugal

Full record on ClinicalTrials.gov

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