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

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

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

Inclusion Criteria3

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);

Exclusion Criteria6

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.

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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