View clinical trials related to Aortic Valve Stenosis.
Filter by:The aim of this study is to investigate the effect of strict blood pressure control versus conventional care in patients with asymptomatic moderate to severe aortic valve stenosis. The study is a randomized (1:1), open label, controlled intervention trial. Hypothesis: 1. Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment. 2. Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment. 3. Strict BP reduction for up to 10 years reduces the need for aortic valve replacement and cardiovascular events compared to conventional care.
A novel, image-based model for estimation of the pressure gradient across stenosed aortic valves is compared against invasively measured pressure gradients from clinical routine.
The objective of this study is to evaluate the safety and performance of the transShield Embolic Protection System (EPS) used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement
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)
This study plans to investigate the relationship between cognitive status pre-procedure, and clinical outcomes at 3 months in patients undergoing transcatheter aortic valve implantation (TAVI).
Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America. Previous evidence shows that aortic valve calcification is an active biological process associated with inflammation. The only actual treatment for severe aortic stenosis is surgical aortic valve replacement (AVR). The materials with which the different types of prostheses are manufactured could induce inflammation per se. Biological prostheses, an incomplete cell removal process and therefore, the presence of residual proteins of animal origin, could induce the immune system's response. In the manufacturing bioprosthesis at the "Ignacio Chávez" National Institute of Cardiology (INC), an evaluation was carried out in the early, and late post-surgical period, it was shown that the inflammatory response after six months is similar to that produced by mechanical prosthesis. This study's main objective is to evaluate the inflammatory response in patients with post-operated AVR due to biological or mechanical prosthetic valve through different plasma biomarkers in long-term follow-up. Research question What is the inflammatory response and calcification in patients who undergo aortic valve replacement for a manufactured prosthesis at the "Ignacio Chávez" National Institute of Cardiology in the long-term follow-up? Hypothesis Manufactured bioprostheses at the "Ignacio Chávez" National Institute of Cardiology show a similar or lower inflammatory response to imported bioprostheses or mechanical prostheses associated with less valve dysfunction and more outstanding durability.
A post-market study of the Edwards SAPIEN 3 Ultra System in subjects with symptomatic, severe, calcific aortic stenosis.
The purpose of the HALT Biomarkers study are to identify a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT) and can be used to supplement the diagnosis of HALT; to characterize changes in circulating proteins after treatment of HALT with systemic anticoagulation; and to identify circulating proteins that predict the occurrence of HALT. The study population will be adult patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) or bioprosthetic valve degeneration. Enrollment will continue until 30 patients with HALT are identified for completion of phase 1. Based on a HALT incidence rate of 10%, we anticipate enrolling 300 patients. Patients are enrolled prior to undergoing transfemoral TAVR. Blood samples, clinical data and echocardiograms will be collected at the following timepoints: baseline (pre-TAVR, T0), post-TAVR (pre-discharge, T1), 30-day follow-up (window 3-9 weeks, T2), and 6-month follow-up (T3). Cardiac 4D CT will be performed at the 30-day follow-up visit to screen for the occurrence of HALT. Patients with HALT will be treated with systemic anticoagulation for 5-6 months, at which point a follow-up CT scan and blood sample will be obtained. Control subjects will also undergo a 6-month study visit with blood sample collection. The study will be conducted within two phases. Phase 1 will serve as a derivation / discovery study in which candidate protein biomarkers of HALT will be identified. Once this is successfully completed, a second cohort will be enrolled within phase 2. Phase 2 will be performed under the auspices a future contract or amendment and will seek to cross-validate the initial study findings.
Transcatheter aortic valve implantation (TAVI) is recommended for patients with severe aortic stenosis (AS) at high to intermediate surgical risk. Despite similar mortality rates compared to surgical aortic valve replacement (SAVR) in this setting, the rate para-valvular leak (PVL) remains higher and has been associated to higher mortality even at mild degree. This is one of the major concerns to extend TAVI to low surgical risk, although the favorable results from PARTNER 3. The presence of moderate to severe PVL after TAVI is associated to a 2- and 3- fold increase in the mortality rate at 30-day and 1-year follow-up, respectively (24-29). Prosthesis-patient mismatch (PPM) adversely affects functional improvement and exercise tolerance, left ventricular (LV) mass regression, and late structural valve deterioration. Many studies have previously investigated PPM after surgical AVR suggesting the presence of this problem in more than 40% of the surgically treated patients. This rate was significantly lower with the balloon-expandable Sapien (Edwards Lifesciences, Irvine, California), with PPM that varied from 8% to 18%, but in both cases (patients harboring TAVI and those with SAVR) the mortality rate was higher in the presence of PPM. Under the hypothesis that there are differences in terms of transvalvular gradients and residual para-valvular leak amongst different balloon-expandable TAVI devices available in the market, the aim of the MATCH-BALL study is to compare the hemodynamic performance of two balloon-expandable TAVI devices, Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) and Myval (Meril Life Sciences Pvt. Ltd., India).