Active clinical trials for "Aortic Valve Stenosis"

Post-market registry aimed at further evaluating the safety and performance of the ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System in patients with severe aortic stenosis treated with the commercialized device

There are procedure related risk factors for permanent pacemaker implantation (PPI) that can be identified and assessed in a prospective cohort of 300 patients at high risk for PPI Prospective, multicenter, European registry in patients at high risk for PPI undergoing TAVI with the Edwards SAPIEN 3 valve. Additional assessment of calcification using a CT data core lab. Statistical analysis of the dataset obtained with respect to the objectives of the registry.

The Eko CORE and DUO stethoscopes are FDA-approved electronic devices that have the capacity to record heart sounds. The study seeks to expand murmur detection to include VHD classification through the development of novel ML algorithms that are able to distinguish between systolic vs. diastolic vs. continuous murmurs, as well as classify VHD type and severity, using 4-point auscultation with Eko CORE and DUO electronic stethoscopes to record heart sounds.

The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.

Transcatheter aortic valve implantation (TAVI) is a standard procedure for severe aortic stenosis patients with moderate or higher risk of surgery. Several studies have reported the adverse effects of blood disorders, such as anemia and iron deficiency, on the prognosis of patients undergoing TAVI, and many other studies have been conducted to find ways to prevent them. Iron isomaltoside, the latest intravenous iron supplement, can effectively replenish iron store with a single high-dose injection. Research has shown that a preoperative single high-dose iron isomaltoside (1000mg) safely increased hemoglobin levels after surgery in patients undergoing cardiac surgery. However, there have been no studies on the effect of ultra-short-term use of intravenous iron supplements prior to TAVI procedure. Therefore, we investigate the effect of a single high-dose of iron isomaltoside (20mg/kg, maximum dose: 1g) on the hemoglobin concentration after the TAVI.

Since the first implantation by Cribier, transcatheter aortic valve implantation (TAVI) revolutionized the management of severe symptomatic aortic stenosis. Indeed, TAVI is indicated as an alternative to conventional surgery in patients at high surgical risk or contra-indicated to conventional surgery. However, TAVI remains associated with specific complications related to the technics itself dominated by vascular complications and conductive disorders. Major vascular complications remain frequent after TAVI despite improvements in operators' experience, patient's selection and lower profile devices. Indeed, according to the Valve Academic Research Consortium 2 (VARC-2) criteria , major VC are still reported with an incidence of 1.5% to 15% of the procedures in registries and may be associated with unfavorable clinical outcomes. Currently, percutaneous approach (PC) in transfemoral TAVI is performed in routine, considered as a less invasive strategy than the traditional surgical cutdown (SC) performed in the first TAVI experience. Indeed, percutaneous approach may facilitate the local anesthesia and does not require the presence of the surgeon in the catheterization laboratory . However, surgical approach is still performed in many centers, allowing a better control of the puncture site with a low rate of vascular complications . Several non-randomized studies compared the two approaches with contradictory results]. No data are available comparing both approaches performed by the same team during the same period. The aim of this study was to compare percutaneous and surgical approaches in terms of vascular complications and bleeding in patients undergoing transfemoral TAVI.

The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.

A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement

Angiogenesis and fibrosis lie at the heart of a number of fundamental processes responsible for cardiovascular disease. In this proposal, the investigators intend to build upon a highly successful programme of studies exploring the cardiovascular applications of positron emission tomography. Specifically, the investigators will explore the potential role of a novel radiotracer, 18F-fluciclatide, which is a highly selective ligand for the αvβ3 and αvβ5 integrin receptors that are up regulated during angiogenesis, and tissue fibrosis and remodelling. This tracer has been successfully used to assess angiogenesis in metastatic tumours and its uptake is suppressed by anti-angiogenic therapies. The investigators here propose to describe the pattern of uptake of 18F-fluciclatide in cardiovascular diseases, specifically aortic stenosis and aortic atherosclerosis. The investigators will correlate 18F-fluciclatide uptake with in vivo measures of angiogenesis and fibrosis as well as ex vivo histological characterisation of tissue. If successful, this novel radiotracer could provide an extremely important non-invasive method of assessing in vivo angiogenesis, plaque vulnerability, and tissue remodelling as well as potential applications in developing stem cell therapies.

Degenerative aortic valve stenosis (AVS) is the leading cause of aortic valve morbidity with a prevalence of 2-7% at ages above 65 years, with ever-increasing incidence especially in the 8th decades. AVS is independently associated with atheroclerosis risk factors and clinically apparent CV disease indicating that the degeneration of the aortic valve may represent an atheroclerosis-like process involving both, the aortic valve as well as the vascular system, respectivel. It is still unknown whether the endothelial function is affected as an manifestation of the atherosclerotic process, changes in the driving mechanical forces as WSS downstream of the valve, or other factors beyond physical pressure effects. The investigators hypothesized that altered haemodynamics may at least partly be responsible for observed endothelial dysfunction in patients with AVS. Therefore, the aim of this study is to investigate whether the resolution of AVS by transaortic valve implacement (TAVI) affects WSS, improves endothelial dysfunction and decreases levels of circulating EMPs as markers of endothelial integrity.