Aortic Valve Stenosis Clinical Trials

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

Status: Recruiting
Location: See all (12) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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);

Locations
Other Locations
Portugal
Hospitais da Universidade de Coimbra
NOT_YET_RECRUITING
Coimbra
Hospital da Luz Coimbra
NOT_YET_RECRUITING
Coimbra
Hospital do Espírito Santo de Évora
NOT_YET_RECRUITING
Evora
Hospital Dr. Nélio Mendonça
NOT_YET_RECRUITING
Funchal
Hospital CUF Tejo
NOT_YET_RECRUITING
Lisbon
Hospital da Luz Lisboa
NOT_YET_RECRUITING
Lisbon
Hospital de Santa Cruz
RECRUITING
Lisbon
Hospital Lusíadas Lisboa
NOT_YET_RECRUITING
Lisbon
Hospital Santa Maria
RECRUITING
Lisbon
Hospital Santa Marta
RECRUITING
Lisbon
Hospital Universitário de São João
RECRUITING
Porto
Hospital Eduardo Santos Silva
NOT_YET_RECRUITING
Vila Nova De Gaia
Contact Information
Primary
Rui C Teles, MD, PhD
rcteles@outlook.com
(+351) 210 433 069
Backup
Joana D Silva, MD, PhD
secretariado.apic@spc.pt
Time Frame
Start Date: 2026-01-14
Estimated Completion Date: 2028-04
Participants
Target number of participants: 500
Treatments
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.
Sponsors
Collaborators: Medtronic
Leads: Portuguese Association of Interventional Cardiology

This content was sourced from clinicaltrials.gov