Actively Recruiting
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Led by Portuguese Association of Interventional Cardiology · Updated on 2026-04-08
500
Participants Needed
12
Research Sites
115 weeks
Total Duration
On this page
Sponsors
P
Portuguese Association of Interventional Cardiology
Lead Sponsor
M
Medtronic
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older who can provide informed consent
- Severe symptomatic aortic stenosis defined as New York Heart Association (NYHA) class II or higher, including symptoms such as shortness of breath, fatigue, chest pain, or fainting
- Provided written informed consent approved by the Ethics Committee
You will not qualify if you...
- Presence of a pre-existing surgical bioprosthetic aortic valve
- Liver failure classified as Child-Pugh Class B or C
- Contraindications for treatment with the Medtronic Evolut FX+ TAVI System according to its instructions for use
- Anatomical conditions unsuitable for the Medtronic Evolut FX+ TAVI System
- Participation in another clinical study that could affect this registry's results
- Expected survival less than one year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Hospitais da Universidade de Coimbra
Coimbra, Coimbra District, Portugal, 3004-561
Not Yet Recruiting
2
Hospital da Luz Coimbra
Coimbra, Coimbra District, Portugal, 3020-479
Not Yet Recruiting
3
Hospital CUF Tejo
Lisbon, Lisbon District, Portugal, 1350-352
Not Yet Recruiting
4
Hospital de Santa Cruz
Lisbon, Lisbon District, Portugal, 1449-005
Actively Recruiting
5
Hospital Lusíadas Lisboa
Lisbon, Lisbon District, Portugal, 1500-458
Not Yet Recruiting
6
Hospital da Luz Lisboa
Lisbon, Lisbon District, Portugal, 1500-650
Not Yet Recruiting
7
Hospital Santa Maria
Lisbon, Lisbon District, Portugal, 1649-035
Actively Recruiting
8
Hospital Santa Marta
Lisbon, Lisbon District, Portugal, 2855-697
Actively Recruiting
9
Hospital Dr. Nélio Mendonça
Funchal, Madeira, Portugal, 9004-514
Not Yet Recruiting
10
Hospital Universitário de São João
Porto, Porto District, Portugal, 4200-319
Actively Recruiting
11
Hospital Eduardo Santos Silva
Vila Nova de Gaia, Vila Nova de Gaia, Portugal, 4434-502
Not Yet Recruiting
12
Hospital do Espírito Santo de Évora
Evora, Évora District, Portugal, 7000-811
Not Yet Recruiting
Research Team
R
Rui C Teles, MD, PhD
CONTACT
J
Joana D Silva, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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