View clinical trials related to Aortic Valve Stenosis.
Filter by:This pilot study is a prospective, randomized, open-label trial that aims to assess the feasibility of comparing a primary Computed tomography/Cardiac computed tomography angiography (CT/CCTA) strategy (test arm) to a strategy combining routine use of CT/CCTA and invasive CA (control arm) prior to a Transcatheter aortic valve implantation (TAVI) procedure. The study will also estimate the rate of composite coronary adverse events (myocardial infarction, post procedural coronary revascularization and cardiovascular mortality) between the two arms at 90 days follow-up. The primary endpoint will be the feasibility of recruitment and compliance with the study protocol at 2 sites in Canada and 1 site in Denmark. Additional clinical endpoints including: all-cause death at 90 days post procedure, myocardial infarction at 90 days post procedure, unplanned PCI or CABG at 90 days post procedure, stroke at 90 days post procedure, CA and PCI related cumulative vascular complications events. This information will be used to inform the design of the definitive efficacy trial.
This translational study was designed to explore the association of the quantity and quality of epicardial adipose tissue (EAT) with coronary artery disease (CAD), left atrial remodeling and postoperative atrial fibrillation in a high cardiovascular disease-risk population. The investigators expect to identify new biochemical factors and biomarkers in the crosstalk between the epicardial adipocytes, coronary plaques and atrial cardiomyocytes that are involved in the pathogenesis of atherosclerosis and atrial fibrillation, respectively.
This study is aimed to investigate the global transcriptome in order to determine the expression profile of messenger RNAs (mRNAs), as well as long noncoding- (lncRNAs) and micro noncoding-RNAs (miRNAs) in heart failure (HF) and in aortic stenosis (AS). The aim is to clarify their role in cardiac disease pathogenesis, as well as their potential as biomarkers. To this purpose, both tissue and blood specimens will be collected and patients will be compared to individuals not affected by cardiovascular diseases.
A single center registry including all patients treated with TAVI at the Heart Center, Bad Segeberg, Germany
Since October of 2014, the Policlinico Umberto I Hospital has an "Heart Team", a group of selected specialists with the task of assessing and identifying eligible patients for valvular aortic transcatheter implantation (TAVI) or a placement of a MitraClip . The specialists taking part to Heart Team are: a cardiologist, a heart surgeon, a vascular surgeon, an anesthesiologist and a geriatrician. The Geriatrician is called to make a careful multidimensional assessment of the elderly patients who have been suggested for the interventions mentioned above. His role is to assess the degree of co-morbidity and polypathology, autonomy in the common activities of daily living, nutritional status, cognitive status and quality of life. Following this evaluation, together with the other components of Heart Team, it is expressed a collective judgment on the patient's eligibility to these interventions. So, the aim of the present study is to identify changes in the degree of cognitive decline, of autonomy in carrying out activities of daily living, quality of life, nutritional status, pre- and postoperatively (6 months after the procedure) polypathology degree in elderly patients to be undergone or undergoing TAVI or positioning MitraClip because suffering from aortic valvular stenosis or severe mitral insufficiency. The patients undergo to a battery of tests, to a 5 minutes electrocardiographic record to evaluate the Heart Rate Variability (HRV) and to a complete echocardiographic evaluation.
Traditional and transcatheter surgical treatments of severe aortic valve stenosis (SAVS) are increasing in parallel with the improved life-expectancy. Recent randomized trials (RCTs) reported comparable or non-inferior mortality with transcatheter treatments compared to traditional surgery. However, RCTs have the limitation of being a mirror of the predefined inclusion/exclusion criteria, without reflecting the "real clinical world". Technological improvements have recently allowed the development of minimally invasive surgical accesses and the use of sutureless valves, but their impact on the clinical scenario is difficult to assess because of the monocentric design of published studies and limited sample-size. A prospective multicentre registry including all patients referred for a surgical treatment of SAVS (traditional, through full-sternotomy; minimally-invasive; or transcatheter; with both "sutured" and "sutureless" valves) will provide a "real-world" picture of available results of current surgical options, and will help to clarify the "grey zones" of current guidelines. E-AVR is a prospective observational open registry designed to collect all data from patients admitted for SAVS, with or without coronary artery disease, in 16 cardiac surgery Centres located in six countries (France, Germany, Italy, Spain, Switzerland, and United Kingdom). Patients will be enrolled over a 2-year period and followed-up for a minimum of 5 years to a maximum of 10 years after enrolment. Outcome definitions are concordant with VARC-2 criteria and established guidelines. Primary outcome is 5-year all-cause mortality. Secondary outcomes aim at establishing "early" 30-day all-cause and cardiovascular mortality, as well as major morbidity, and "late" cardio-vascular mortality, major morbidity, structural and non-structural valve complications, quality of life and echocardiographic results. The study protocol is approved by Local Ethics Committees. Any formal presentation or publication of data will be considered as a joint publication by the participating physician(s) and will follow the recommendations of the International Committee of Medical Journal Editors (ICMJE) for authorship.
The primary purpose of this study is electronic data collection of arterial pressure waveform signals in patients with Aortic Stenosis. The collected digital pressure waveform data will be used to assess the feasibility of using the arterial pressure signal as a decision support tool for early detection of aortic stenosis conditions. Furthermore we evaluate hemodynamic parameters before and after valve repair and its correlation with outcome.
This study sought to evaluate changes in ascending aorta size after transcatheter aortic valve replacement (TAVR) in patients with bicuspid aortic valve (BiAV) compared with patients with tricuspid aortic valve (TAV).
Aortic stenosis (AS) is the most common valvular heart disease. Once symptomatic with severe AS, outcome is poor unless the valve is replaced surgically or via transcatheter aortic valve replacement (TAVR). Transthyretin amyloid (ATTR) deposits are common in the heart muscle in up to 25% of octogenarians, and after an asymptomatic period of unknown duration, cause overt heart failure and arrhythmias in a proportion of cases. The prevalence and impact of covert ATTR amyloidosis in elderly individuals with AS are unknown. Detection would avoid misdiagnosis, guide treatment and, potentially, improve outcomes. Recent data have shown that echocardiography, cardiovascular magnetic resonance (CMR), computed tomography (CT), and DPD scintigraphy, can identify ATTR amyloid deposits, but the clinical performance of these various tests is unknown. This study will investigate elderly patients with symptomatic severe AS using imaging to explore ATTR amyloid in AS and determine its prevalence and impact on outcome. The investigators aim to recruit a total of 250 patients aged 75 or older being considered for intervention for severe AS. The prevalence of cardiac amyloid will be assessed in three arms (sAVR, TAVI and medical therapy, with a likely patient ratio of 50:150:50), using five investigation modalities - all cohorts (echocardiography and DPD scintigraphy); sAVR cohort (biopsy and CMR); TAVI cohort (EqCT); medical therapy only cohort (as per work-up/trial prior to no intervention decision). The primary outcome measure is patient mortality. Secondary outcomes measures are major adverse cardiovascular events, length of stay, pacemaker implantation, ECV measured by EqCT and CMR. Follow up will be at 1-year with clinical echocardiogram (for sAVR and TAVI patients) and/or telephone interview for all patients (if not carried out in person at the time of the echocardiogram).
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.