View clinical trials related to Aortic Valve Stenosis.
Filter by:The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with severe symptomatic aortic stenosis who are considered at high or extreme risk for surgical aortic valve replacement.
BACKGROUND.- The frailty syndrome (FS) associates an increase in morbidity and mortality in the elderly patient. When severe and symptomatic, aortic stenosis (AS) is a disease with poor prognosis, the most frequent cause of heart surgery in the elderly and associates high health costs. No variables have been identified as determinants of morbidity and mortality of these patients and there are not algorithms developed for treatment decision-making in this particular population. The FS as a functional reserve indicator could be a prognostic and interventional treatment tolerance marker, and should be included in the selection of patients for surgical treatment. The FS and cardiovascular disease (CVD) share biological substrates among which an inflammatory state associates poor prognosis. OBJECTIVES .- To evaluate the effectiveness of the diagnosis of FS to characterize the prognosis of elderly patients with severe symptomatic AS representative of clinical practice. In addition, to examine the contribution of an inflammatory state to the relationship of FS with the prognosis of severe, symptomatic AS. METHODS .- Prospective study during 12 months of 200 patients > 74 years old with severe symptomatic AS. During the index visit the main clinical characteristics will be recorded and in addition we will perform a comprehensive geriatric assessment, FS assessmet according to Fried et al criteria (strength, walking speed, physical activity, fatigue, unintentional weight loss) and determination of inflammatory markers (C-reactive protein and interleukin-6). During follow-up, measures of functional impairment (basic and instrumental activities of daily living, walking speed and timed set up & go test), hospitalizations, death and quality of life will be determined.
This study aims to evaluate whether baseline 18F-sodium fluoride uptake activity at aortic valve could predict aortic stenosis progression in moderate aortic stenosis. Patients with moderate aortic stenosis are enrolled and underwent baseline evaluation including 18F-sodium fluoride PET/CT. After 1 year, all the participants underwent follow-up echocardiography. The study design is an observational trial. Primary endpoint was a change in mean pressure gradient along the aortic valve as assessed by echocardiography at 1 year. Secondary endpoints include changes in aortic valve area, and symptom occurrence.
Currently catheters used in heart catheterization procedures are guided throughout the heart chambers and blood vessels by pictures taken by x-rays. This technology exposes patients to radiation. With this study protocol the investigators will use MRI technology to take real-time pictures to navigate catheters throughout heart chambers. MRI uses electromagnetic energy; therefore, it does not expose participants to radiation energy.
The study objective is to evaluate safety and efficacy of the Medtronic TAVR (Transcatheter Aortic Valve Replacement) 2.0 system in patients with severe symptomatic aortic stenosis who are considered at high through extreme risk for surgical aortic valve replacement
Aim of the study is to demonstrate equivalence of second-generation self-expandable valves (CoreValve Evolut R) in comparison to second-generation balloon-expandable valves (Edwards Sapien 3) and of local anesthesia with conscious sedation in comparison to general anesthesia with respect to safety and efficacy in high-risk patients with severe aortic stenosis undergoing transcatheter aortic valve implantation.
To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.
Balloon predilatation of the aortic valve has been regarded as an essential step during the transcatheter aortic valve implantation (TAVI) procedure. However, recent evidence suggested that aortic valvuloplasty may be harmful and that high success rate may be obtained without prior dilatation of the valve. We hypothesize that TAVI performed without predilatation and using new generation balloon expandable prothesis is associated with a better net clinical benefit in comparison with procedure performed with pre dilatation.
Investigators sought to demonstrate that the increase in the stroke volume during a dobutamine stress echocardiography might impact the prognosis of a patient addressed for a low flow low gradient suspected severe aortic valve stenosis.
This is a single-center, single-blind, all comer, randomized controlled trial. Patients scheduled for isolated aortic valve replacement (AVR) due to aortic stenosis at "Virgen de la Victoria Universitary Hospital", Málaga, Spain, will be eligible. Ninety-six patients will be randomly assigned to either partial upper sternotomy (ministernotomy, 48 patients) or full sternotomy AVR (48 patients). Sample size was determined for an Alpha error of 0.05,and Beta error of 0.1 for a power of 90% in detecting 0.10 difference points in quality of life EQ-5D-5L-index or 10 points in EQ-5D-5L-Visual Analogic Scale (QOL).