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PERFECT: Portuguese registry of Medtronic Evolut FX+ TAVI with an optimized implantation care pathway

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

Observational Portuguese Association of Interventional Cardiology · NCT07343674

This registry will try the Medtronic Evolut FX+ catheter valve with a standardized implantation approach in adults with severe symptomatic aortic stenosis to see if it improves safety and recovery.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorPortuguese Association of Interventional Cardiology Academic / other
Locations12 sites (Coimbra, Coimbra District and 11 other locations)
Trial IDNCT07343674 on ClinicalTrials.gov

What this trial studies

This is an observational registry enrolling about 500 adults with severe symptomatic aortic stenosis treated with the Medtronic Evolut FX+ TAVI system as part of routine care across 12 hospitals in Portugal. The program implements a standardized implantation pathway (including cusp overlap technique) and collects procedural details, complications, and device performance. Participants are followed during the hospital stay, and at 30 days and 1 year to record outcomes such as pacemaker implantation, complications, and valve function. The collected data will describe short- and long-term safety and effectiveness of the device and the standardized care pathway across multiple centers.

Who should consider this trial

Good fit: Adults (≥18 years) with severe symptomatic aortic stenosis (NYHA class ≥ II) who are candidates for TAVI, can give informed consent, and are anatomically suitable for the Evolut FX+ system are ideal candidates.

Not a fit: Patients with a pre-existing surgical aortic bioprosthesis, significant hepatic insufficiency (Child-Pugh B/C), anatomical contraindications to the Evolut FX+, expected survival under one year, or other contraindications per the device instructions are unlikely to benefit from participating.

Why it matters

Potential benefit: If successful, this could lead to safer, more consistent TAVI procedures with fewer complications and improved recovery for patients.

How similar studies have performed: Previous registries and trials of the Evolut family and use of cusp-overlap implantation have reported favorable outcomes, but applying a standardized Evolut FX+ care pathway across multiple Portuguese centers is relatively new.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Coimbra, Coimbra District and 11 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Severe Symptomatic Aortic Stenosis Class ≥ II)TAVITranscatheter Aortic Valve ImplantationEvolut FX+Aortic StenosisCusp Overlap TechniqueConduction DisordersEvolut FX+ TAVI System
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.