View clinical trials related to Aortic Valve Stenosis.
Filter by:Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study. The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.
The study purpose is to compare the EDWARDS INTUITY valve system in a minimal invasive surgical approach (MIS) with any commercially available aortic bioprosthesis in standard full sternotomy surgical approach.
A single-center prospective interventional trial. Patients implanted with a sutureless bioprosthetic aortic valve at Karolinska University Hospital in Stockholm, Sweden from 2012 will be eligible. 4-dimensional volume-rendered computed tomography (CT) of the heart will be performed. The aim of the CT is to assess valve leaflet motion. Results of the CT examination, preoperative clinical characteristics, and postoperative clinical data will be registered. Data will be collected prospectively and retrospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.
ATLANTIS is a multicenter, phase IIIb, prospective, open-label, randomized trial. The objective of this study is to demonstrate superiority of a strategy of anticoagulation with apixaban (Anti-Xa Group) as compared to the current standard of care in patients who have undergone a successful TAVI procedure. The randomization is stratified according to the presence or not of a mandatory indication for anticoagulation for a reason other than the TAVI procedure (e.g. atrial fibrillation or DVT/PE).
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to safety and performance of the device.
The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.
Aortic stenosis (AS) is the most common valve disease among the adult population, in the majority of the cases it only requires treatment in advanced age. Transcatheter aortic valve implantation (TAVI) has become available as an alternative treatment for very high risk or even inoperative patients who are suffering from symptomatic aortic stenosis. Until now it has been learnt that there are group of patients who are in a very bad condition and who are so frail that they do not benefit from TAVI. These patients have worse survival rate and more importantly poor quality of life in spite of a successful procedure. Cardiac surgery risk scores like Society of Thoracic surgery score (STS) and EUROSCORE are less accurate in aging high risk people. In elderly it is principal to make differentiation between utility and futility. On the other hand, beside frailty status the main barrier to TAVI is the risk of neurological impairment. Neurological injury and impairment in TAVI can occur as cerebrovascular event (CVE) and/or neurocognitive dysfunction. The two neurocognitive dysfunctions - post-operative delirium (POD) and post-operative cognitive dysfunction (POCD). Most cases remain undetected although clinically could be apparent or silent. The neurological injury can be observed and/or detected by neuroimaging techniques and cognitive trajectories. A well established and validated frailty score based on relatively simple and feasible tests could help in our everyday practice to evaluate the prognosis of elderly people undergoing TAVI and to determine those patients who really benefit from the procedure.
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
This study will quantify the safety and efficacy of the CardioCel implant in tri-leaflet repair. 80 patients in up to 7 sites in Europe and the US will all be treated with the CardioCel implant.
To assess the safety and feasibility of Transcatheter Aortic Valve Replacement (TAVR) with commercially available bioprostheses in patients with severe, symptomatic aortic stenosis (AS) who are low-risk (STS score ≤3%) for surgical aortic valve replacement (SAVR).