View clinical trials related to Aortic Valve Stenosis.
Filter by:This study will monitor device performance and safety of the Edwards CENTERA Transcatheter Heart Valve (THV) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.
Study the consequences on heart muscle of the stenosis aortic valve before and after the replacement procedure, the repercussion on heart. Study the impact on the heart of "sick" valve can affect on "well-being" and prognosis in the year following the surgery.
According to current European Recommendations on valvular heart disease (VHD), "classical" severe aortic stenosis (AS) is defined by an aortic valve area (AVA) ≤1 cm2 and indexed AVA ≤0.6 cm2/m2, a mean aortic pressure gradient (MAG) >40 mmHg, and a maximal aortic velocity >4 m/sec. Aortic valve replacement (AVR) is recommended (class I indication) in patients with "classical" severe AS who have any symptoms related to aortic valve disease. In 2007, Hachicha et al. described a particular pattern of severe AS, characterized by an AVA ≤0.6 cm2/m2, low mean pressure aortic gradient (MAG <40 mmHg), despite the presence of a preserved left ventricular ejection fraction (LVEF ≥50%). This pattern of AS is encountered in nearly 15-25 % of patients who have severe AS. Typically, these patients are elderly subjects, with several comorbidities, a small left ventricular (LV) cavity with pronounced LV concentric remodeling and a restrictive physiology, leading to a decrease in LV stroke volume despite a preserved LVEF. The diagnosis and management of patients with low gradient severe AS and preserved LVEF are often challenging because: 1. the presence of a "true" severe aortic stenosis should be carefully confirmed by a multi-modality imaging approach; 2. the best therapeutic management (AVR versus conservative strategy) of symptomatic patients with low gradient severe AS and preserved LVEF is not clearly established. In very recently updated European guidelines on the management of VHD, symptomatic patients with low gradient and low flow severe AS and preserved LVEF have only a class IIa-level C indication for AVR. No specific indications are given for the management of symptomatic patients with low gradient and normal flow severe AS. This lack of indications is clearly attributed to a gap in knowledge which requires further investigations to be filled up.
This study is to analyse if the size of the valve can be determined with a preoperative CT scan of the heart in order to prepare the valve preoperatively to save time.
Prospective, open-label, multicenter, European registry with a follow-up of 5 years to assess the clinical outcomes of patients younger than 60 years who undergo surgical AVR with the INSPIRIS RESILIA Aortic Valve™.
To compare changes in Left Ventricular Mass (LVM) depending on each blood pressure regulation between the intensive care group and the usual care group for patients with hypertension accompanied by aortic valve disease and evaluate an influence of blood pressure regulation on improvement of left ventricular hypertrophy and its safety
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after TAVR so as to investigate whether FFRct is useful for evaluating myocardial ischemia of severe AS. Furthermore, by measuring the instantaneous wave-free ratio (iFR) which is a physiological diagnostic method of coronary artery stenosis before and after TAVR and comparing iFR (iFR before and after TAVR) and FFR (FFR after TAVR) with FFRct (FFRct before and after TAVR), It also aims to deepen understanding of resting coronary artery physiology in aortic valve stenosis.
Early Check provides voluntary screening of newborns for a selected panel of conditions. The study has three main objectives: 1) develop and implement an approach to identify affected infants, 2) address the impact on infants and families who screen positive, and 3) evaluate the Early Check program. The Early Check screening will lead to earlier identification of newborns with rare health conditions in addition to providing important data on the implementation of this model program. Early diagnosis may result in health and development benefits for the newborns. Infants who have newborn screening in North Carolina will be eligible to participate, equating to over 120,000 eligible infants a year. Over 95% of participants are expected to screen negative. Newborns who screen positive and their parents are invited to additional research activities and services. Parents can enroll eligible newborns on the Early Check electronic Research Portal. Screening tests are conducted on residual blood from existing newborn screening dried blood spots. Confirmatory testing is provided free-of-charge for infants who screen positive, and carrier testing is provided to mothers of infants with fragile X. Affected newborns have a physical and developmental evaluation. Their parents have genetic counseling and are invited to participate in surveys and interviews. Ongoing evaluation of the program includes additional parent interviews.
Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear. Current European guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months.The prevalence of subclinical leaflet thrombosis after TAVI is 15% up to 40%, but its clinical long-term relevance is uncertain. Thromboelastography (TEG(R)) can be used as a point-of-care system evaluating a patient's individual hemostasis profile. For the detection of transcatheter valve thrombosis it may be superior to conventional platelet function testing because global hemostasis can be assessed in addition to platelet function. The investigators intend an observational trial recruiting patients undergoing TAVI under standard care. At defined time points the investigators will serially perform TEG(R) as well as further platelet function testing (multiple electrode aggregometry) and conventional coagulation testing. The primary objective is to find surrogate TEG-derived markers / models predicting the development of a subclinical leaflet thrombosis after TAVI under usual care. The secondary objective is to find TEG-derived markers / models identifying patients at an increased risk after TAVI (all-cause mortality, cardiovascular mortality, thromboembolic and bleeding events).
TAVI is still a relatively new technique that is emerging with advance in the percutaneous and implantable valve technology. Despite its safe use in inoperable and high risk patients with severe symptomatic aortic valve stenosis, minimizing complications, predictors of outcomes and approach preference is still an area of study. Here we decided to study the outcomes of patients undergoing TAVI, different approaches used and their subsequent results and complications.