New heart valve registry aims to improve safety and outcomes

NCT ID NCT07343674

Recruiting now Disease control Sponsor: Portuguese Association of Interventional Cardiology Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This registry is following 500 adults in Portugal who have severe aortic stenosis and are getting a new type of heart valve replacement called the Medtronic Evolut FX+ TAVI system. The goal is to see if using a standardized procedure makes the treatment safer and more effective. Participants will be checked during their hospital stay, at 30 days, and at one year to track recovery, valve function, and any complications.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Medtronic Evolut™ FX+ TAVI System (a device for replacing the aortic valve without open-heart surgery)
What this could lead to: If successful, this could help standardize the TAVI procedure to improve safety and reduce complications like the need for a pacemaker.
What could go wrong: This is an observational registry, not a controlled trial, so results may not prove cause and effect. Risks include procedural complications, need for a pacemaker, or valve problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis Arrhythmias, Cardiac

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SEVERE SYMPTOMATIC AORTIC STENOSIS (DEFINED AS NEW YORK HEART ASSOCIATION (NYHA) CLASS ≥ II)

Contacts and locations

Locations

Hospitais da Universidade de Coimbra
RECRUITING

Coimbra, Coimbra District, 3004-561, Portugal
Hospital CUF Tejo
RECRUITING

Lisbon, Lisbon District, 1350-352, Portugal
Hospital Dr. Nélio Mendonça
NOT_YET_RECRUITING

Funchal, Madeira, 9004-514, Portugal
Hospital Eduardo Santos Silva
NOT_YET_RECRUITING

Vila Nova de Gaia, Vila Nova de Gaia, 4434-502, Portugal
Hospital Lusíadas Lisboa
NOT_YET_RECRUITING

Lisbon, Lisbon District, 1500-458, Portugal
Hospital Santa Maria
RECRUITING

Lisbon, Lisbon District, 1649-035, Portugal
Hospital Santa Marta
RECRUITING

Lisbon, Lisbon District, 2855-697, Portugal
Hospital Universitário de São João
RECRUITING

Porto, Porto District, 4200-319, Portugal
Hospital da Luz Coimbra
NOT_YET_RECRUITING

Coimbra, Coimbra District, 3020-479, Portugal
Hospital da Luz Lisboa
NOT_YET_RECRUITING

Lisbon, Lisbon District, 1500-650, Portugal
Hospital de Santa Cruz
RECRUITING

Lisbon, Lisbon District, 1449-005, Portugal
Hospital do Espírito Santo de Évora
NOT_YET_RECRUITING

Evora, Évora District, 7000-811, Portugal