View clinical trials related to Severe Aortic Valve Stenosis.
Filter by:The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure. Only patients without an indication for anticoagulants will be included in this trial. Currently, lifelong single antiplatelet therapy (mostly aspirin) is considered the standard of care for these patients. However, this approach poses a bleeding risk with only a minimal reduction in thromboembolic events. After 3 months, a CT scan will be conducted to assess the presence of thrombosis on the newly implanted TAVI valve. Based on the results of a 4D CT scan, the decision will be made whether the patient should receive no anticoagulant or antithrombotic therapy with apixaban. CT-guided antithrombotic therapy holds the potential for a greater reduction in thromboembolic events without increasing the bleeding risk.
In the past decade the treatment of aortic valve stenosis has rapidly changed. At first, transcatheter aortic valve implantation (TAVI) was a last resort option for inoperable patients. Nowadays, it more and more becomes an alternative to surgical aortic valve replacement (SAVR) - also in younger and lower risk patients. This poses important questions to clinical practise regarding the optimal life-time management of each individual patient. Which involves (durability of) treatment modality (surgical vs. transcatheter vs. conservative treatment) as well as the duration and type of the required antithrombotic treatment. Objective: to evaluate the effect of treatment modality (surgical vs. transcatheter vs. conservative treatment) and its complications on quality of life and survival in AoS patients.
This study will assess hemodynamic changes induced after spinal anesthesia by evaluating vasopressor inotropic requirements and variations in echocardiographic parameters in patients having severe aortic stenosis or severe mitral regurgitation undergoing aortic or mitral valve replacement surgery.
The goal of this prospective, multi-center, randomized, controlled study is to compare the safety and efficacy of the ProtEmbo Cerebral Embolic Protection device to a hybrid control (no embolic protection device ('No Device') and the Sentinel device) in subjects with severe symptomatic native aortic valve stenosis indicated undergoing a TAVR procedure.
The objective of this study is to evaluate the ACURATE Neo2 in the Middle East population with severe, symptomatic aortic stenosis.
To evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis.
This prospective, randomized-controlled multicenter study investigates whether virtual reality-assisted patient education in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) can improve patient understanding and simulative orientation, thereby reducing postinterventional complications, resulting in significantly shorter length of stay.
The optimal pharmacological therapy after transcatheter aortic valve implantation (TAVI) to prevent valve thrombosis and reduce thromboembolic complications without significantly increasing the risk of bleeding is not yet fully defined and constitutes an important unmet clinical need. Recently, single antiplatelet therapy (SAPT) with Aspirin has been increasingly adopted to avoid bleeding early after TAVI compared with dual antiplatelet therapy. However, TAVI population is affected by a diversity of chronic pathologies that increase the risk of post-TAVI ischemic complications. Stroke is prevalent, especially peri- and early post-TAVI (<1-8% in the 1st year). Although peri-TAVI myocardial infarction (MI) is rare (1-3%), concomitant coronary artery disease (CAD), diabetes mellitus (DM), and peripheral vascular disease (PVD), is very frequent in the TAVI population, affecting around 30-70% of patients. In patients with CAD, the need to re-access the coronary arteries after TAVI is challenging and can be hampered by the trancatheter valve struts. This is critical in TAVI patients with an acute coronary syndrome and in younger patients with long-life expectancy after TAVI. The use of a P2Y12 inhibitor provides significant ischemic protection in the in the coronary, cerebral and peripheral vascular territories compare to Aspirin. The use of a P2Y12 inhibitor as antiplatelet treatment can decrease the need for new coronary revascularizations and reduce the incidence of thromboembolic complications after TAVI.
A prospective, non-randomized, single-arm, single-center, first-in-human study designed to evaluate the safety and feasibility of the DurAVR™ THV System in the treatment of subjects with symptomatic severe aortic stenosis.
Background: Transcatheter aortic valve replacement (TAVR) has become the preferred therapy for aortic stenosis. Given the growing life-expectancy, the risk of requiring coronary interventions or of developing prosthesis degeneration that could require TAVR-in-TAVR for its treatment progressively increases. During standard TAVI procedures the native and the prosthesis commissures are randomly aligned with misalignment in up to 70% of the cases. This might hinder coronary re-access in 18% of the cases, increase the risk of coronary obstruction during future TAVR-in-TAVR procedures, and has been associated to greater residual gradients. Methods: Although several techniques have been developed to increase the degree of commissural alignment, all are imperfect or imply manipulation of the system within the patient, potentially increasing the risk of complications. The research team developed a software based on computed tomography analysis that allows planification of accurate commissural alignment by inserting the delivery system in a patient-specific degree of rotation. Aim: The proponent team aimed to prospectively validate this methodology comparing a cohort of patients harboring TAVR with Acurate Commissural Alignment (ACA) vs. a control cohort with non-ACA standard technique, in order to determine benefits in terms of coronary re-access and clinical events (coronary events, valve degeneration, and TAVR-in-TAVR).