Aortic Valve Stenosis Clinical Trial
Official title:
Multicenter Ambispective Study of Clinical Outcomes of the CoreValve™Evolut R™ 34mm System: All Comers Post-market Registry
With the introduction of the CoreValve™ Evolut R™ 34mm (Medtronic™) prosthesis, patients with severe symptomatic aortic stenosis (AS) and large aortic annulus have become eligible for transcatheter aortic valve implantation (TAVI). The aim of this study is to detect the number of TAVI candidates with large aortic annulus, and to evaluate the feasibility, efficacy, and safety of TAVI using the CoreValve™ Evolut R™ 34mm.
With the current transcatheter valves available in the market, is possible to cover a wide
range of patients with diverse and complex anatomies. Nevertheless, there is a subgroup of
patient with large aortic annulus (diameter > 27 mm), in whom the implant of a transcatheter
valve is not possible because there is no valve suitable for such as aortic annulus size.
With the introduction of the CoreValveTM EvolutionTM R 34mm, patients with an aorttic annulus
dimension up to 29 mm in diameter have become eligible for TAVI. However, there is a lack of
information regarding the number of patient with AS and this particular anatomy of the aortic
annulus. Italian and Dutch registries have reported a prevalence between 6.5 to 12.3% with
large aortic annulus requiring the previous CoreValveTM 31mm. Yet, there is no reported data
regarding this population of patients in Spain. Also, the clinical use of this larger
prosthesis covers a wider range of aortic rings and may enchance the procedural challenges,
such as a little margin for proper valve placement, more likelihood of interference with
mitral valve function and damage to the cardiac conduction system during the prosthesis
deployment.
So far, no studies regarding clinical experiences with the CoreValveTM EvolutionTM R 34mm
have been published. The scarce information currently available with this new device may be
distant from those found in its daily clinical use in non-selected patients. The results of
this Spanish nationwide registry will help to answer a scientific need of information
regarding acute procedural results and mid
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