NCT07343674

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Portuguese Association of Interventional Cardiology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Timeline

• Start date: 2026-01-14
• Primary completion: 2027-11-01
• Completion: 2028-04-01
• First posted: 2026-01-15
• Last updated: 2026-04-08

Locations

12 sites across 1 country: Portugal