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

N/ANot Yet RecruitingNCT07343674

Portuguese Association of Interventional Cardiology500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (12)

Hospitais da Universidade de Coimbra

Coimbra, Coimbra District, Portugal

Hospital da Luz Coimbra

Coimbra, Coimbra District, Portugal

Hospital CUF Tejo

Lisbon, Lisbon District, Portugal

Hospital de Santa Cruz

Lisbon, Lisbon District, Portugal

Hospital Lusíadas Lisboa

Lisbon, Lisbon District, Portugal

Hospital da Luz Lisboa

Lisbon, Lisbon District, Portugal

Hospital Santa Maria

Lisbon, Lisbon District, Portugal

Hospital Santa Marta

Lisbon, Lisbon District, Portugal

Hospital Dr. Nélio Mendonça

Funchal, Madeira, Portugal

Hospital Universitário de São João

Porto, Porto District, Portugal

...and 2 more locations

Outcomes

Primary Outcomes

VARC-3 technical success

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).

Time frame: Immediately after the index procedure

Secondary Outcomes

Rate of Permanent Pacemaker Implantation (PPI)

Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances.

Time frame: 30 days after procedure

Length of Hospital Stay

Number of days from TAVI procedure to discharge.

Time frame: Up to 30 days after procedure

All-Cause Mortality

Death from any cause.