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

Portuguese Association of Interventional Cardiology

Status: Not yet enrolling

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT07343674

PERFECT Registry

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

500 participants in 1 patient group

Patients with severe aortic stenosis undergoing Medtronic Evolut FX+ TAVI System

Description:

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.