PERFECT: Portuguese registry of Medtronic Evolut FX+ TAVI with an optimized implantation care pathway
Official title: PERFECT - Portuguese Evolut Registry Studying the Outcomes of Medtronic Evolut™ FX+ TAVI System by Evaluating an Optimal Care Pathway for TAVI
Run by Portuguese Association of Interventional Cardiology · NCT07343674 · Data updated 2026-11-12
This registry will try the Medtronic Evolut FX+ catheter valve with a standardized implantation approach in adults with severe symptomatic aortic stenosis to see if it improves safety and recovery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Portuguese Association of Interventional Cardiology Academic / other |
| Locations | 12 sites (Coimbra, Coimbra District and 11 other locations) |
| Status | Recruiting |
| Started | January 14, 2026 |
| Main results expected | November 2027 |
| Study ends | April 2028 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07343674 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with severe symptomatic aortic stenosis (NYHA class ≥ II) who are candidates for TAVI, can give informed consent, and are anatomically suitable for the Evolut FX+ system are ideal candidates.
✕Probably not a fit
Patients with a pre-existing surgical aortic bioprosthesis, significant hepatic insufficiency (Child-Pugh B/C), anatomical contraindications to the Evolut FX+, expected survival under one year, or other contraindications per the device instructions are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational registry enrolling about 500 adults with severe symptomatic aortic stenosis treated with the Medtronic Evolut FX+ TAVI system as part of routine care across 12 hospitals in Portugal. The program implements a standardized implantation pathway (including cusp overlap technique) and collects procedural details, complications, and device performance. Participants are followed during the hospital stay, and at 30 days and 1 year to record outcomes such as pacemaker implantation, complications, and valve function. The collected data will describe short- and long-term safety and effectiveness of the device and the standardized care pathway across multiple centers.
Why it matters
Potential benefit: If successful, this could lead to safer, more consistent TAVI procedures with fewer complications and improved recovery for patients.
How similar studies have gone: Previous registries and trials of the Evolut family and use of cusp-overlap implantation have reported favorable outcomes, but applying a standardized Evolut FX+ care pathway across multiple Portuguese centers is relatively new.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hospitais da Universidade de Coimbra
Coimbra, Coimbra District, Portugal Recruiting -
Hospital CUF Tejo
Lisbon, Lisbon District, Portugal Recruiting -
Hospital de Santa Cruz
Lisbon, Lisbon District, Portugal Recruiting -
Hospital Santa Maria
Lisbon, Lisbon District, Portugal Recruiting -
Hospital Santa Marta
Lisbon, Lisbon District, Portugal Recruiting -
Hospital Dr. Nélio Mendonça
Funchal, Madeira, Portugal Recruiting
Show 6 more locations
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Hospital Universitário de São João
Porto, Porto District, Portugal Recruiting -
Hospital Eduardo Santos Silva
Vila Nova de Gaia, Vila Nova de Gaia, Portugal Recruiting -
Hospital da Luz Coimbra
Coimbra, Coimbra District, Portugal Not yet recruiting -
Hospital Lusíadas Lisboa
Lisbon, Lisbon District, Portugal Not yet recruiting -
Hospital da Luz Lisboa
Lisbon, Lisbon District, Portugal Not yet recruiting -
Hospital do Espírito Santo de Évora
Evora, Évora District, Portugal Not yet recruiting
Study contacts
- Principal investigator: Rui C Teles, MD, PhD — Hospital de Santa Cruz - Unidade Local de Saúde de Lisboa Ocidental
- Study coordinator: Rui C Teles, MD, PhD
- Email: rcteles@outlook.com
- Phone: (+351) 210 433 069
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.