PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Key facts
- Who runs it
- Portuguese Association of Interventional Cardiology
- Where
- Coimbra, Evora, Funchal, Lisbon, Porto, and Vila Nova de Gaia, PortugalSee the 12 sites
- Trial code
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 14 Jan 2026
- Expected to end
- Apr 2028
- Type of study
- Observational
- Record updated
- 14 October 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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)
Who cannot take part
- Subjects with pre-existing surgical bioprosthetic aortic valve
- Contraindicated for treatment with the Medtronic Evolut™ FX+ TAVU System in accordance with the Instructions for Use (IFU)
- Hepatic insufficiency (Child-Pugh Class B or C)
- 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 in Portugal
- Hospitais da universidade de CoimbraCoimbra, PortugalContact: Joana D Silva, MD, PhDTaking people
- Hospital da Luz CoimbraCoimbra, PortugalContact: Marco Costa, MDNot yet recruiting
- Hospital do Espírito Santo de ÉvoraEvora, PortugalContact: Lino Patrício, MD, PhDNot yet recruiting
- Hospital Dr. Nélio MendonçaFunchal, PortugalContact: Bruno Silva, MDTaking people
- Hospital Cuf TejoLisbon, PortugalContact: António Fiarresga, MD, PhDTaking people
- Hospital da Luz LisboaLisbon, PortugalContact: Pedro Gonçaves, MD, PhDNot yet recruiting
- Hospital de Santa CruzLisbon, PortugalContact: João Brito, MDTaking people
- Hospital Lusíadas LisboaLisbon, PortugalContact: Eduardo I Oliveira, MDNot yet recruiting
- Hospital Santa MariaLisbon, PortugalContact: Pedro C Ferreira, MDTaking people
- Hospital Santa MartaLisbon, PortugalContact: Duarte Cacela, MDTaking people
- Hospital Universitário de São JoãoPorto, PortugalContact: Ricardo Lopes, MDTaking people
- Hospital Eduardo Santos SilvaVila Nova de Gaia, PortugalContact: Pedro Braga, MDTaking people
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Patients with severe aortic stenosis undergoing Medtronic Evolut FX+ TAVI System
Subjects with severe, symptomatic aortic stenosis (AS) with indication for TAVI (Transcatheter Aortic Valve Implant) with the Medtronic Evolut™ FX+ TAVI System - registry of routine practice.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 14 October 2026