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

NCT07343674 | Recruiting

• 1 other identifier: PERFECT Registry
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 12

Brief 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)

Keywords

TAVI; Transcatheter Aortic Valve Implantation; Evolut FX+; Aortic Stenosis; Cusp Overlap Technique; Conduction Disorders; Evolut FX+ TAVI System; TAVI System

Outcome Measures

Primary Outcomes (1)

• 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).

  Immediately after the index procedure

Secondary Outcomes (11)

• Rate of Permanent Pacemaker Implantation (PPI)

  30 days after procedure

• Length of Hospital Stay

  Up to 30 days after procedure

• All-Cause Mortality

  30 days and 1 year

• Stroke

  30 days and 1 year

• Life-Threatening Bleeding

  30 days and 1 year

Other Outcomes (2)

• Procedural Technique Compliance (TAVI.PTrainer Survey)

  During the index procedure

• Correlation of Procedural Compliance with Clinical Outcomes

  Procedure through 1 year

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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);

You may not qualify if:

• 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.

Sponsors & Collaborators

• Portuguese Association of Interventional Cardiology: lead
• Medtronic: collaborator

Study Sites (12)

Hospitais da Universidade de Coimbra

Coimbra, Coimbra District, 3004-561, Portugal

NOT YET RECRUITING

Hospital da Luz Coimbra

Coimbra, Coimbra District, 3020-479, Portugal

NOT YET RECRUITING

Hospital CUF Tejo

Lisbon, Lisbon District, 1350-352, Portugal

NOT YET RECRUITING

Hospital de Santa Cruz

Lisbon, Lisbon District, 1449-005, Portugal

RECRUITING

Hospital Lusíadas Lisboa

Lisbon, Lisbon District, 1500-458, Portugal

NOT YET RECRUITING

Hospital da Luz Lisboa

Lisbon, Lisbon District, 1500-650, Portugal

NOT YET RECRUITING

Hospital Santa Maria

Lisbon, Lisbon District, 1649-035, Portugal

RECRUITING

Hospital Santa Marta

Lisbon, Lisbon District, 2855-697, Portugal

RECRUITING

Hospital Dr. Nélio Mendonça

Funchal, Madeira, 9004-514, Portugal

NOT YET RECRUITING

Hospital Universitário de São João

Porto, Porto District, 4200-319, Portugal

RECRUITING

Hospital Eduardo Santos Silva

Vila Nova de Gaia, Vila Nova de Gaia, 4434-502, Portugal

NOT YET RECRUITING

Hospital do Espírito Santo de Évora

Evora, Évora District, 7000-811, Portugal

NOT YET RECRUITING

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MeSH Terms

Conditions

Aortic Valve Stenosis; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rui C Teles, MD, PhD

  Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rui C Teles, MD, PhD

CONTACT

(+351) 210 433 069; rcteles@outlook.com

Joana D Silva, MD, PhD

CONTACT

secretariado.apic@spc.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 15, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PT (12)