View clinical trials related to Aortic Valve Stenosis.
Filter by:Aortic stenosis (AS) is characterised by left ventricular (LV) hypertrophy and altered myocardial substrate metabolism. Peroxisome proliferator-activated receptor (PPARα), a regulator of lipid metabolism is deactivated in pressure overload hypertrophy such as in AS and can lead to dysregulation of fatty acid oxidation, myocardial triglyceride accumulation (steatosis) and lipotoxicity. The investigators propose a proof-of-concept study to investigate the effect of altering myocardial triglyceride (MTG) using a PPARα agonist, fenofibrate on cardiac physiology in patients with asymptomatic moderate-severe AS. The primary endpoint is a change in MTG assessed by magnetic resonance spectroscopy at baseline and after 6 months of treatment. Exploratory endpoints are changes in cardiac physiology including myocardial deformation (strain) as assessed by cardiac magnetic resonance imaging. The investigators hypothesise that pharmacological reduction of MTG with a PPARα agonist will result in steatosis regression and changes in cardiac physiology.
COPAS pilot is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using colchicine, on valvular calcification activity using imaging, i.e. aortic valvular NaF uptake. The current proposal uses a randomized design to evaluate the effect of colchicine vs. placebo on valvular calcification activity over 6 months measured using NaF PET
The CAS study is a prospective observational cohort study investigating the effects of congenital aortic stenosis (ConAoS) on the left ventricular function and the prevalence, pattern and expanse of left ventricular hypertrophy (LVH), myocardial stiffness and myocardial fibrosis.
Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.
Randomized, double-blinded, placebo-controlled study in AS patients with subclinical or clinical heart failure undergoing treatment with TAVR.
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI). Once a diagnosis has been made and the decision to treat these patients has been taken, the procedure (AVR or TAVI) must be performed rapidly given the poor prognosis of the disease without treatment. Studies have shown that on the waiting list, the probability of death and hospitalisation for heart failure increases with time. This delay could also reduce the effectiveness of TAVI, thus affecting the performance of the healthcare system. In this study, an intervention combining an e-health component (tool intended for patients, families and health professionals in contact with patients), and an organisational component (for TAVI implanting centres) has been designed. The aim of this study is to evaluate the effectiveness of this intervention.
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
Aortic stenosis (AS) is the most common valvular heart disease among elderly population, with a increasing prevalence due to population ageing. In developed countries, the prevalence of severe AS among ≥75 years is approximately 3.4%. The onset of symptoms is associated with a poor prognosis. Indeed, mortality increases once symptoms appears. For several decades, surgical aortic valve replacement (SAVR) has been the standard of care for symptomatic AS. Transcatheter aortic valve implantation (TAVI) was introduced as alternative treatment in inoperable patients in 2002. In the last two decades TAVI has led to a paradigm shift in the treatment of severe AS, representing a less invasive alternative to surgery. TAVI has shown to be non-inferior or superior to SAVR in several large-scale randomized clinical trials (RCTs) across the full spectrum of surgical risks. The newly available evidence has led to an expansion of guideline recommendations for TAVI. Furthermore, newer generations of transcatheter heart valve (THV) design, better patient selection, and technical enhancements have driven improvement in safety and reduction of procedural complications over time. This observational study aim to prospectively evaluate the safety and efficacy of the procedure and clinical outcomes in patients undergoing TAVI.
OBJECTIVE: To evaluate changes in cognitive performance in the early postoperative (1 month) and late (1 year) postoperative period in patients undergoing aortic valve replacement (SVAo) with surgery (SVA_Q) or transcatheter aortic valve implant (TAVI), by neuropsychological study (NRP), structural Brain Magnetic Resonance (sMRI) and functional MRI (fMRI). The specific objectives are: (1) to compare the early and late clinical-functional consequences with NRP study in both groups; (2) to compare the occurrence of cerebral clinical events during follow-up; (3) to quantify and compare the appearance of silent lesions in the early postoperative period and late of SVAo with sMRI with respect to the baseline MRI in both groups; (4) study with fMRI changes in the activity and functional connectivity and correlate them with the NRP findings in all patients in the early and late phase in comparison with the basal MRI. METHODOLOGY: Prospective longitudinal, unicentric, nonrandomized cohort study of consecutive patients> 70 years, with indication for SVAo and intermediate and high surgical risk. One month before surgery will be performed an sMRI and fMRI and a baseline NRP study. One month after surgery, sMRI, fMRI and NRP study will be performed to assess the appearance of new lesions, as well as changes in cognitive performance with respect to baseline cognitive status. One year later, sMRI, fMRI and NRP study will be performed to assess changes in cognitive status with respect to baseline and early postoperative. Response variables: changes in cognitive performance measured by a Global Cognitive Impairment Index and in cognitive status (normal vs. Mild Cognitive Impairment vs Moderate Impairment), number, size and location of new silent brain lesions, cerebral vascular clinical events, and changes in advanced neuroimaging (image by diffusion tensor (DTI), resting-state fMRI) and its relationship with cognitive changes.
The aim of the study is to evaluate the effect of antifibrotic therapy on regression of myocardial fibrosis after TAVI in patients with baseline high fibrotic burden. Therefore, patients will be treated with Spironolactone in addition to standard of care, Spioronolactone + Dihydralazine in addition to standard of care or according to standard of care alone without any study medication. First, differences between patients in the control arm and patients randomized to anti-fibrotic therapy will be analyzed. The second analysis will determine, whether dihydralazine medication in addition to spironolactone is able to increase a potential antifibrotic effect. Myocardial fibrosis will be assessed by cardiac magnetic resonance imaging (CMR) before TAVI and 1 year after. Quantification of potentially irreversible replacement fibrosis will be carried out by late gadolinium enhancement (LGE), and quantification of the potentially reversible diffuse interstitial fibrosis will be performed by measurement of the extracellular volume fraction (ECV), thereby deriving matrix volume and cell volume.