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

April 7, 2026 updated by: Portuguese Association of Interventional Cardiology

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Portugal
    • Coimbra District
      • Coimbra, Coimbra District, Portugal, 3004-561
        • Not yet recruiting
        • Hospitais da universidade de Coimbra
        • Contact:
        • Principal Investigator:
          • Joana D Silva, MD, PhD
      • Coimbra, Coimbra District, Portugal, 3020-479
        • Not yet recruiting
        • Hospital da Luz Coimbra
        • Contact:
        • Principal Investigator:
          • Marco Costa, MD
    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1350-352
        • Not yet recruiting
        • Hospital CUF Tejo
        • Contact:
        • Principal Investigator:
          • António Fiarresga, MD, PhD
      • Lisbon, Lisbon District, Portugal, 1449-005
        • Recruiting
        • Hospital de Santa Cruz
        • Principal Investigator:
          • João Brito, MD
        • Contact:
      • Lisbon, Lisbon District, Portugal, 1500-458
        • Not yet recruiting
        • Hospital Lusíadas Lisboa
        • Contact:
        • Principal Investigator:
          • Eduardo I Oliveira, MD
      • Lisbon, Lisbon District, Portugal, 1500-650
        • Not yet recruiting
        • Hospital Da Luz Lisboa
        • Contact:
        • Principal Investigator:
          • Pedro Gonçalves, MD, PhD
      • Lisbon, Lisbon District, Portugal, 1649-035
        • Recruiting
        • Hospital Santa Maria
        • Principal Investigator:
          • Pedro C Ferreira, MD
        • Contact:
      • Lisbon, Lisbon District, Portugal, 2855-697
        • Recruiting
        • Hospital Santa Marta
        • Principal Investigator:
          • Duarte Cacela, MD
        • Contact:
    • Madeira
      • Funchal, Madeira, Portugal, 9004-514
        • Not yet recruiting
        • Hospital Dr. Nelio Mendonca
        • Contact:
        • Principal Investigator:
          • Bruno Silva, MD
    • Porto District
      • Porto, Porto District, Portugal, 4200-319
        • Recruiting
        • Hospital Universitário de São João
        • Contact:
        • Principal Investigator:
          • Ricardo Lopes, MD
    • Vila Nova de Gaia
      • Vila Nova de Gaia, Vila Nova de Gaia, Portugal, 4434-502
        • Not yet recruiting
        • Hospital Eduardo Santos Silva
        • Principal Investigator:
          • Pedro Braga, MD
        • Contact:
    • Évora District
      • Evora, Évora District, Portugal, 7000-811
        • Not yet recruiting
        • Hospital do Espírito Santo de Évora
        • Contact:
        • Principal Investigator:
          • Lino Patrício, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

  • 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);

Exclusion Criteria:

  • 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;
  • Subjects are currently participating in another clinical investigation that may confound the results of this Registry;
  • Subjects have an expected survival less than one year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VARC-3 technical success
Time Frame: Immediately after the index procedure
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).
Immediately after the index procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Permanent Pacemaker Implantation (PPI)
Time Frame: 30 days after procedure
Percentage of participants who require a new permanent pacemaker due to new or worsening conduction disturbances.
30 days after procedure
Length of Hospital Stay
Time Frame: Up to 30 days after procedure
Number of days from TAVI procedure to discharge.
Up to 30 days after procedure
All-Cause Mortality
Time Frame: 30 days and 1 year
Death from any cause.
30 days and 1 year
Stroke
Time Frame: 30 days and 1 year
Any new neurologic deficit classified as a stroke by clinical evaluation.
30 days and 1 year
Life-Threatening Bleeding
Time Frame: 30 days and 1 year
Severe bleeding events defined by VARC-3 criteria.
30 days and 1 year
Acute Kidney Injury
Time Frame: 30 days and 1 year
Kidney dysfunction as defined by VARC-3 criteria.
30 days and 1 year
Coronary Artery Obstruction
Time Frame: 30 days and 1 year
Blockage requiring clinical intervention.
30 days and 1 year
Major Vascular Complications
Time Frame: 30 days and 1 year
Serious vascular complications as defined by VARC-3 criteria
30 days and 1 year
Valve Dysfunction Requiring Reintervention
Time Frame: 30 days and 1 year
Prosthetic valve dysfunction that requires repeat procedure.
30 days and 1 year
Rehospitalization
Time Frame: 30 days and 1 year
Rehospitalization for valve-related symptoms or worsening heart failure.
30 days and 1 year
Prosthetic Valve Function
Time Frame: 30 days and 1 year

Echocardiographic measures of valve function: left ventricular ejection fraction, peak velocity, mean gradient, effective orifice area, indexed effective orifice area, and prosthetic aortic valve regurgitation.

It is defined as YES if: peak velocity is < 3 m/s AND mean gradient < 20 mmHg AND DVI > 0,25* AND Regurgitation < moderate (this means that LV and index EOA are indirectly in it, no cutt offs are needed)

* DVI is the ratio of the Velocity-Time Integral (VTI) in the Left Ventricular Outflow Tract (LVOT) to the VTI across the stenotic aortic valve. It is measured based on the peak velocity /Grad, Effective orifice area (cm²)
30 days and 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Technique Compliance (TAVI.PTrainer Survey)
Time Frame: During the index procedure
Assessment of operator adherence to standardized TAVI procedural steps, including Cusp Overlap Technique, using a dedicated checklist tool.
During the index procedure
Correlation of Procedural Compliance with Clinical Outcomes
Time Frame: Procedure through 1 year
Analysis of whether higher compliance with optimized TAVI procedural steps is associated with better patient outcomes.
Procedure through 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Portuguese Association of Interventional Cardiology

Collaborators

Medtronic

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

January 8, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PERFECT Registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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