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

NCT07343674 · tracked via the Priya Life Science Portugal tracker

Sponsor

Portuguese Association of Interventional Cardiology

Phase

Observational

Started

2026-01-14

Last updated

2026-07-02

Condition(s) studied

Severe Symptomatic Aortic Stenosis (Defined as New York Heart Association (NYHA) Class ≥ II)

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

VARC-3 technical success — Immediately after the index procedure
A composite outcome assessed immediately after the TAVI procedure, including: survival, successful vascular access and device deployment/retrieval, correct positioning of a single valve, and freedom from major complications or need for surgery/intervention (excluding pacemaker).

Trial sites (12)

Facility	City	Region	Status
Hospitais da Universidade de Coimbra	Coimbra	Coimbra District	Recruiting
Hospital da Luz Coimbra	Coimbra	Coimbra District	Not Yet Recruiting
Hospital CUF Tejo	Lisbon	Lisbon District	Recruiting
Hospital de Santa Cruz	Lisbon	Lisbon District	Recruiting
Hospital Lusíadas Lisboa	Lisbon	Lisbon District	Not Yet Recruiting
Hospital da Luz Lisboa	Lisbon	Lisbon District	Not Yet Recruiting
Hospital Santa Maria	Lisbon	Lisbon District	Recruiting
Hospital Santa Marta	Lisbon	Lisbon District	Recruiting
Hospital Dr. Nélio Mendonça	Funchal	Madeira	Not Yet Recruiting
Hospital Universitário de São João	Porto	Porto District	Recruiting
Hospital Eduardo Santos Silva	Vila Nova de Gaia	Vila Nova de Gaia	Not Yet Recruiting
Hospital do Espírito Santo de Évora	Evora	Évora District	Not Yet Recruiting

More Portuguese Association of Interventional Cardiology trials in Portugal

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07343674 on ClinicalTrials.gov ↗ ← All trials in Portugal