RecruitingNot Applicable

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

Portugal500 participantsStarted 2026-01-14

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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 Criteria: * 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.

What they're measuring

VARC-3 technical success

Timeframe: Immediately after the index procedure

Trial details

NCT IDNCT07343674

SponsorPortuguese Association of Interventional Cardiology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-11

Contact for this trial

Rui C Teles, MD, PhD

(+351) 210 433 069 rcteles@outlook.com