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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

NCT07343674 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-04-08

No results posted yet for this study

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)

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Portuguese Association of Interventional Cardiology

    lead OTHER

Principal Investigators

  • Rui C Teles, MD, PhD · Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-14
Primary Completion
2027-11-30
Completion
2028-04-30

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07343674 on ClinicalTrials.gov