An observational study in Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, sponsored by Fundacin Biomedica Galicia Sur. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Fundacin Biomedica Galicia Sur · Observational
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
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →Fundacin Biomedica Galicia Sur is the lead sponsor of 27 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with severe symptomatic aortic stenosis undergo TAVI using the CoreValve™ Evolut R™ 34 mm will be included
Exclusion Criteria:
All consecutive real-world patients with aortic stenosis selected for TAVI as part of routine clinical care, using a CoreValve™ Evolut R™ 34mm during the inclusion period will be entered the registry.
Safety: Stroke
Stroke (disabling), dichotomous qualitative variable: yes/no
Time frame: 12 months
Efficacy: prosthetic regurgitation at early post TAVI
Percent of subjects with ≤ mild prosthetic regurgitation at early post-implant (mild, Moderate or Severe)
Time frame: 12 months
Safety:Incidence of permanent pacemaker implant rate
Incidence of permanent pacemaker implant rate, dichotomous qualitative variable: yes/no
Time frame: 12 months
Plan to share: Undecided
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Fundacin Biomedica Galicia Sur