View clinical trials related to Aortic Valve Stenosis.
Filter by:Transcatheter aortic valve replacement TAVR is become the reference method for patients with severe aortic stenosis who are contraindicated or at risk for surgical aortic replacement. Initially performed under general anesthesia (GA), recent developpement of minimalist approach of TAVR include the use of local anesthesia (LA) with or without conscious sedation (CS) associated with full percutaneous access and no routine transoesophageal echocardiography (T0E). The aim is to simplify the procedure and to allow fast recovery of patients with early discharge and reduced cost. Evidence guiding the decision of whether to perform TAVR under GA or LA-CS is limited to non-randomized trials and registry data Current evidence is however limited by probable patient selection bias, methodological variability between studies, various methods of anesthesia and a lack of agreement regarding appropriate clinical end-points. The potential benefits of TAVR with LA include reduced procedure time, shorter intensive care unit (ICU) length of stay, reduced need for intraprocedural vasopressor support, and the potential to perform the procedure without the direct presence of an anesthetist for cost-saving reasons. As LA with CS is preferred with good results in main centers, GA may be useful to facilitate intraprocedural TOE which is necessary in case of intraprocedural complications and may facilitate the procedure for the physician particularly when the patient is anxious or disturbed. A resulted better concentration without precipitation may influence the outcomes in term of valve positioning. The patient comfort could also be better during femoral puncture or rapid pacing. The aim of the study is to compare transfemoral TAVR under general anesthesia (experimental group) versus local anaesthesia with sedation (control group) with a safety primary combined end point of adverse events at 72 h follow-up (hemodynamic parameters and VARC 3 criteria). Secondary end points include hospitalization length, satisfaction of the patients and operators and 30 days mortality. The hypothesis is a non inferoirity of the GA staregy regarding the primary end point.
This study evaluates and compares aortic calcium by computed tomography and histopathology in patients with aortic stenosis.
Background and Project Rationale: Degenerative aortic valve stenosis affects 2% of the elderly population aged 70 years or older and progresses insidiously with advancing age [1] before manifesting with symptoms such as decreased exercise tolerance, shortness of breath, chest pain and syncope on exertion. Without aortic valve replacement, the survival prognosis of patients with symptomatic aortic stenosis is poor. In the PARTNER 1B trial, all-cause mortality among 179 inoperable patients with severe symptomatic aortic stenosis allocated to conservative management amounted to 51% at one year [2]. Consistently, prospective registry data reported a mortality rate of 55% at 1 year in 78 patients with severe aortic stenosis undergoing conservative management [3]. The rapid spread of the SARS-CoV-2 pandemic represents an unprecedented challenge for healthcare systems. A limited number of ventilators and ICU beds call for a careful allocation of healthcare resources. On March 20 2020, the Federal Council prohibited elective interventions in all hospitals in Switzerland. Patients with untreated severe aortic stenosis are particularly vulnerable to SARS-CoV-2 infection [4] and face the dual risk of cardiac death from aortic stenosis on one side, and death from acute respiratory distress syndrome secondary to SARS-CoV-2 infection on the other. While the balance between the two risks is a matter of clinical judgement, the investigators established an algorithm for the management of patients with severe aortic stenosis during the SARS-CoV-2 pandemic. Patients with aortic stenosis deemed critical will undergo valvular replacement in spite of the ongoing pandemic while patients with severe but not critical aortic stenosis will undergo deferred intervention once the number of new SARS-CoV-2 infections flattens. In the current situation, aortic valve replacement in patients with severe, non-critical aortic stenosis will be deferred in order to give priority to SARS-CoV-2 patients. This unique situation allows the investigators to study the effect of deferral of aortic valve replacement in patients with severe aortic stenosis. The study is an amendment to the Swiss-TAVI registry. In contrast to the Swiss-TAVI registry, patients are not enrolled at the time of aortic valve replacement, but already at the time of referral for aortic valve replacement. Primary Objective: The aim of the present observational study is to explore the effect of deferral of valvular replacement in patients with severe but not critical aortic stenosis on morbidity and mortality. The primary objective is to describe rates of morbidity and mortality among patients with severe but not critical aortic stenosis in the interval from referral/indication for valvular replacement to intervention. Project Design: The study is a prospective cohort study of patients with severe aortic stenosis referred for aortic valve replacement. All referrals for aortic valve replacement will be allocated to either "transcatheter aortic valve replacement (TAVR)/ surgical aortic valve replacement (SAVR) (standard of care)" or "deferred intervention" based on prespecified criteria. Patients with critical aortic stenosis as defined by an aortic valve area (AVA) <0.6 cm2 or a transvalvular mean gradient of >60 mmHg or a history of cardiac decompensation during the previous 3 months or clinical symptoms on minimal exertion (NYHA III) will be allocated to TAVR or SAVR. All other patients with severe aortic stenosis defined by an AVA <1.0 cm2 will be scheduled for a deferred intervention.
The narrowing of the aortic valve, which prevents blood from reaching the entire body correctly is a common disease in our environment. To correct this problem, many patients undergo Transcatheter Aortic Valve Implantation (TAVI) according to standard clinical practice. Patients have to continue with a specific pharmacological treatment (antiplatelet agents) to avoid possible complications during the first months after the procedure. This treatment is not yet well established. Current guidelines recommend dual antiplatelet therapy with Aspirin and Clopidogrel for 3-6 months after TAVI to avoid thromboembolic complications. But the risk of bleeding events with DAPT in this population is not negligible. This study aims to determine the degree of response to Ticagrelor 60 mg every 12 hours as a single antiplatelet strategy in patients who do not achieve an adequate response with Clopidogrel 75mg every 24 hours. The study will evaluate if patients have an adequate response to Clopidogrel and if not, then patients will start treatment with Ticagrelor 60 mg every 12 hours after TAVI and until completing 3 months of treatment.
Severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. Our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic stenosis affects heart rate variability, inflammation markers and endothelial function.
Retrospective, observational study to compare the outcomes of patient receiving TAVI through transfemoral and transaxillary fully percutaneous approach adjusting for main baseline differences.
Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic valve stenosis. Pain and anxiety are major contributors to procedural complications. Virtual Reality (VR) glasses have already been used successfully in different clinical settings to treat anxiety and delirium. The aim of this prospective, randomized investigation is to prove the feasibility and safety of VR interventions in patients undergoing conscious sedation during TAVI with local anesthesia only.
A Multicenter, prospective, non-randomized, trial evaluating the safety and clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves, implanted in patients with severe aortic stenosis and the impact of predilatation in comparison with the Medtronic CoreValve EvolutT R/PRO systems from the DIRECT trial.
This registry is designed to quantify embolic debris capture rate in patients at low surgical risk treated with the Sentinel System during TAVI.
This project will evaluate the impact of a patient decision aid created by the American College of Cardiology for patients considering treatment of aortic stenosis. The decision aid describes surgical aortic valve replacement (SAVR) surgery and transcatheter valve replacement surgery (TAVR).