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PERFECT - Portuguese Evolut R...

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

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rui C Teles, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental

Locations

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Hospitais da Universidade de Coimbra

Coimbra, Coimbra District, Portugal

Site Status