Clinical trials

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.

Drug-eluting stents (DES) have been the main treatment option for coronary angioplasty (PCI) for many years. The antiproliferative drug in DES has the effect of preventing in-stent restenosis, which is typically a consequence of intimal hyperplasia, a characteristic phenomenon of bare metal stents (BMS). DES have shown to be safe and effective in many clinical and anatomical scenarios. There are, however, several caveats to DES, like restenosis, thrombosis, accelerated atherosclerosis, impossibility of surgical revascularization and disruption of vessel dynamics. These phenomena have a very meaningful negative impact on patient outcomes. Drug-coated balloons (DCB) may avoid those limitations of DES and are an appealing alternative in many different scenarios. They have been the mainstay treatment of in-stent restenosis (ISR) and were formally recommended for this setting in internationally, although recent guidelines recommend DES over a DCB for a first DES restenosis. There is, however, solid evidence for their use in the context of any ISR (BMS or DES-related) and both comparing with POBA or DES. The presence of metal from previous stents makes the implantation of more stents even more of a thing to avoid. High bleeding risk may also be an advantageous setting for DCB, as it may allow for a shorter or less intensive anti-thrombotic treatment with the same or even improved safety endpoints when compared to BMS or DES with standard therapy. Other than ISR, there are other particularly appealing anatomical settings for DCBs such as bifurcations, small vessels and diffuse disease. In the setting of a bifurcation where only the side branch is to be treated, there is evidence that DCB is a good option and provides significantly less late luminal loss when compared to POBA. In case a stent is used in the main branch, a DCB is also a good option for the side branch. In small vessels (\<3,0mm), in which the stent metal would be more conspicuous relative to the smaller lumen, there is strong evidence pointing to a benefit of DCB when compared to balloon angioplasty (POBA) and results at least as good as full-DES. A similar MACE rate between DCB and DES has been reported, with a benefit for DCB in terms of bleeding. In fact, also in larger vessels, DCB may lead to similarly good outcomes. DCB (alone or in combination with DES) is a good alternative to DES-only in diffuse disease. Provided that a good lesion preparation is achieved and there is no structural compromise to the vessel, the lack of a metal stent will be of benefit for any type of lesion. It will contribute to late lumen enlargement (LLE), which can happen in 40-56% of lesions treated with DCB7 and is associated with layered plaques by OCT and medial dissection after lesion preparation. Evidence for DCBs is increasing in different anatomical and clinical contexts, and there are some dedicated recommendations and consensus regarding their use. There is some data regarding real-world clinical performance of DCBs, but there is still the need for large real-world studies with different DCBs, techniques, clinical settings and anatomical contexts with long term follow-up, which is the main driver for this registry.

A prospective, single-arm, multi-centre registry to evaluate the safety and performance of Myval THV series using Transcatheter Aortic Valve Implantation (TAVI) procedure in patients with symptomatic severe native aortic valve stenosis.