View clinical trials related to Aortic Stenosis, Calcific.
Filter by:This study objective is to establish the safety and effectiveness of the Edwards SAPIEN 3 / SAPIEN 3 Ultra / SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve systems in subjects with moderate, calcific aortic stenosis. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
The method of transcatheter aortic valve implantation (TAVI) introduced in 2002 by Alain Cribier et al. has offered new prospects for patients with severe aortic stenosis and multiple comorbidities, who are at high operative risk(1). The PARTNER series of randomized controlled trials has firmly established the role of TAVI with the balloon-expandable Edwards Sapien valve in patients with severe symptomatic aortic stenosis (AS) at prohibitive risk of surgery (PARTNER IA), high risk for surgery (PARTNER IB), and intermediate risk for surgery (PARTNER 2).(2) Also PARTNER 3 and Evolut Low Risk trial strongly suggest that TAVI is not only a suitable alternative and may be superior to surgical aortic valve replacement ( SAVR) in low-risk patients.(2) The accurate determination of the size of the implant is dependent on pre-procedural imaging. Annular measurements are important in the TAVI as inaccurate estimation can lead to complications e.g paravalvular leakage .(3) Transthoracic echocardiography (TTE), transoesophageal echocardiography (TOE), multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) have been extensively studied with respect to pre-procedural aortic annular sizing.(3). However, even with some of the evidence returning a discrepancy in annular measurements between techniques, the literature to date does not clarify whether TOE undersizes inappropriately or appropriately with respect to MDCT.(3) In a recent study, 29.5% of patients would have been deemed ineligible for TAVI because of overestimation of annular measurements by MDCT, a figure reduced to 1.3% with the use of TOE (4) In a recent small retrospective study, TOE, MDCT and MRI all performed comparatively well with device sizing. (5) Balloon aortic valvuloplasty (BAV) dilatation before TAVI is considered a mandatory procedural step in the early years of TAVR. BAV is used to confirm annular sizing and to enhance trans-catheter heart valve (THV) deliverability.(6) However till now there is no comparison of annular measurement by 2D transesophgeal echocardiography with balloon sizing.
At the Malcom Randall Veterans Affairs Medical Center (MRVAMC), invasive cardiac pressures are routinely recorded after transcatheter aortic valve replacement (TAVR) procedures. Our research has disclosed that patients with abnormal hemodynamics (narrow aortic to ventricular end-diastolic pressure difference, indexed to heart rate) suffer from high long-term mortality, compared with patients with normal hemodynamics.This hemodynamic value can be referred to as the aortoventricular index (AVi). Hypertension and diastolic dysfunction are highly co-morbid conditions among these patients. The selective aldosterone receptor antagonist eplerenone (Inspra) is approved for use in the treatment of hypertension. Research also supports that eplerenone may be able to improve diastolic function. This prospective study is interested in determining 1) the tolerability of eplerenone, and 2) feasibility of administering the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) among subject with abnormal cardiac hemodynamics after TAVR. This study will set the stage for a pilot randomized trial to evaluate eplerenone versus placebo among patients with abnormal hemodynamics after TAVR.
Degenerative aortic valve stenosis (AS) is the most common valve heart disease in the developed Western countries. The hemodynamic progression of AS occurs over time and leads to LV hypertrophy (LVH) as a compensation mechanism of the heart. Morphological changes such as increasing muscle fibre thickness, collagen volume, and interstitial fibrosis occur in AS patients. These changes result in left ventricular (LV) diastolic and systolic dysfunction and, consequently, to with AS related symptoms. When symptoms associated with AS appear, patients' prognosis is poor if surgical aortic valve replacement (SAVR) or a trans-catheter aortic valve implantation (TAVI) is not performed. Primary hypothesis of the research: fibrotic changes in the myocardium are related to immediate (in hospital) or long-term complications (MACE and all-cause mortality) in patients with severe AS. The goal of the study is to determine the prognostic implications of focal as well as diffuse myocardial fibrosis in patients with severe aortic valve stenosis.
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.