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

Recruitingn/aAges 18 Years - anyAllPortuguese Association of Interventional Cardiolo…
NCT07343674 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

12 sites
Hospitais da Universidade de Coimbra
Coimbra, Portugal
Hospital da Luz Coimbra
Coimbra, Portugal
Hospital CUF Tejo
Lisbon, Portugal
Hospital de Santa Cruz
Lisbon, Portugal
Hospital Lusíadas Lisboa
Lisbon, Portugal
Hospital da Luz Lisboa
Lisbon, Portugal
Hospital Santa Maria
Lisbon, Portugal
Hospital Santa Marta
Lisbon, Portugal

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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