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.
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);
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;
The study population includes patients with severe, symptomatic AS with indication for TAVI, who meet the criteria for use of the Medtronic EvolutTM FX+ System in accordance with IFU and local regulations.
Cohort
Prospective
Not listed
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).
Rate of Permanent Pacemaker Implantation (PPI)
Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances.
Length of Hospital Stay
Number of days from TAVI procedure to discharge.
All-Cause Mortality
Death from any cause.
Stroke
Any new neurologic deficit classified as a stroke by clinical evaluation.
Procedural Technique Compliance (TAVI.PTrainer Survey)
Assessment of operator adherence to standardized TAVI procedural steps, including Cusp Overlap Technique, using a dedicated checklist tool.
Correlation of Procedural Compliance with Clinical Outcomes
Analysis of whether higher compliance with optimized TAVI procedural steps is associated with better patient outcomes.
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Portuguese Association of Interventional Cardiology
Lead sponsor
Medtronic
Collaborator
