Active clinical trials for "Aortic Valve Stenosis"

J-Valve TF Compassionate Use cases approved on a case by case basis by the FDA

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).

The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.

Aortic stenosis is the most common heart valve disease requiring intervention in high income countries. It is characterised by progressive valvular thickening, and restriction as well is hypertrophy and fibrosis of the left ventricle in response to pressure overload. The pathological processes in the left ventricle that ultimately result in heart failure and death are incompletely understood. Further elucidation of these processes and how they correlate with novel blood biomarkers may help us design new treatments and optimise the timing of surgical intervention. In brief, recruited patients with severe aortic stenosis and scheduled to undergo valve replacement surgery will be invited for some simple tests (blood sampling, ECG, echocardiogram). A septal myocardial biopsy will be taken at the time of surgery and the disease valve retained. These will be examined histologically and pathological changes compared with results obtained from ECG, echocardiogram and blood tests.

Calcified aortic stenosis is the most frequent valvulopathy in Europe and North America. Aortic stenosis is an obstacle to the ejection of blood from the left ventricle to the aorta and leads to morphological changes in the left ventricle and hemodynamic modifications. Intrinsic ventricular performance can be characterized using three parameters: Ventricular elastance (Ees for End Systolic Elastance) which represents the index of ventricular contractility independently of the load. Arterial elastance (Ea for Arterial Elastance) which represents the post-load The ventriculo-arterial coupling index (Ees / Ea) which represents energy efficiency. For patients with high surgical risk (EuroSCORE II> 6), TAVI (Transcatheter Aortic Valve Implantation) is recommended for aortic valve replacement. Many complications may occur after TAVI (haemorrhagic, embolic, renal, myocardial ischemia). Post-TAVI complications may also be cardiac decompensation of the underlying cardiac disease to cardiogenic shock. However, literature on left ventricular performance after aortic valvular replacement is poor because of the difficulty and invasiveness of the analysis involved. Cardiac energy analysis plays an additional role in understanding the clinical patients conditions. On this point, cardiac energy modifications, based on ventriculo-arterial coupling, could be indicators of cardiac function. Two methods (ultrasound and pulse contour) are used to understand and explore the ventriculo-arterial coupling, preload, postload, contractility and hemodynamic changes interactions. Echocardiography allows the Ees / Ea and SW / PVA (Stoke work/ pressure-volume area) ratios mesurements. PRAM (Pressure Recording Analytical Method) through the MostCare® monitor, gives common hemodynamic parameters and more specific parameters such as arterial elastance (Ea) cardiac cycle efficiency (CCE), dP / dt. Cardiac cycle efficiency (CCE) is an exclusive variable that describes the hemodynamic performance in terms of energy expenditure in the patient being followed. TAVI procedure is an acute model of ventriculo-arterial coupling modification by treatment of the ventricular ejection obstacle. The PRAM method evaluates the ventriculo-arterial coupling. The aim of our study is to evaluate by PRAM the changes in cardiac energy variables before and after aortic valve replacement by TAVI

Prospective non interventional, observational registry of 150 patients undergoing TAVI with Evolut platform for bicuspid aortic stenosis.

The aim of this retrospective, multicenter study is to demonstrate that the use of EndoNaut for aortoiliac endovascular procedures has a clinical impact for the patient (reduction in irradiation and the volume of contrast product) as well as for the nursing staff (reduction irradiation) compared to procedures performed without EndoNaut.

Study Objectives/Specific Aims Overall Goal: To study the outcomes of patients undergoing TAVI, their subsequent results and complications. Objective 1: Identify risk factors that are predictive of the need for TAVI and CABG Objective3:Assess early 3 months outcomes and postoperative results Outcome Measure: 1. All-cause mortality within 3 months. Secondary Outcome Measures: Stroke Myocardial infarction Bleeding Hospital stay Acute kidney injury Number of patients with conduction disturbance and pacemaker implantation Gradient on implanted valve Degree of transvalvular leakage 6 weeks follow-up 3 months Echo

This study investigates the association between level of suPAR and valvular heart disease in patients who have severe aortic stenosis or severe aortic regurgitation using commercially available suPARnostic standard enzyme-linked immunosorbent assay (ViroGates, Denmark)

Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those > 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown. Objective: The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI. Since the first case described in 2002, TAVI (transcatheter Aortic Valve Implantation) revolutionized the management of severe symptomatic aortic stenosis. Initially reserved for patients with prohibitive surgical risk, transfemoral TAVI in now indicated according to European Guidelines for patients at intermediate surgical risk and those > 75 ans. Post-procedure intensive care admission (ICU), initially considered as the rule regarding the risk of complications, (particularly conductive disorders), may be avoided in 1/3 of patients regarding drastic reduction in serious complications and growing experience of operators as the investigator shown in a previous prospective study. Predictive criteria for low-risk of complications were therefore established by our team and may be used in routine to select patients that might avoid ICU. However, long-term impact of this triage strategy remains unknown. Objective: The objective of this study is to assess 1-year outcomes according to unit admission selection (ICU or conventional care unit (CCU)) in patients undergoing TAVI.