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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

Key facts

Who runs it
Portuguese Association of Interventional Cardiology
Where
Portugal12 sites in 1 countryChoose a country to see its 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
14 October 2026