View clinical trials related to Heart Valve Diseases.
Filter by:XueBiJing, a Chinese herbal derived therapeutic, has been approved to treat severe infections (sepsis) in critically ill patients (China Food and Drug Administration; Beijing, China, Number Z20040033). Cardiopulmonary bypass (CPB) will produce large amounts of inflammatory mediators and oxygen free radicals, which causes the lipid peroxidation damage and mononuclear cell migration, thus aggravating organ inflammation and damage. Therefore, exploring new methods to prevent and alleviate organ injury caused by CPB is an important topi in clinical practice. However, little knowledge is regarding the effect of Xuebijing injection on CPB-related organ injury. To answer these questions, the authors conducted this randomized trial to compare XueBiJing with placebo in critically ill patients with cardiovascular surgery.
Prospective, single-center, clinical registry of patients with symptomatic/critical carotid artery stenosis at risk of stroke coexisting with unstable or multivessel severe coronary artery disease and/or severe valvular heart disease undergoing endovascular treatment of carotid atherosclerosis using a mesh stent in combination with cardiac surgery (coronary artery bypass grafting (CABG) and/or valve surgery). A study involving clinical data evaluation of truly simultaneous treatment outcomes in patients deemed to require carotid revascularization at the time of surgical cardiac intervention (single-stage, simultaneous treatment). An open-label study, without randomization - a single arm study. Academic Registry - scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University and John Paul II Hospital.
The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.
Non-obstetrical drivers of adverse pregnancy outcomes are underappreciated. Latent structural heart disease may account for a substantial proportion of adverse pregnancy outcomes in low-resource settings. Pregnant women presenting to B.P. Koirala Institute of Health Sciences will be prospectively included into a registry upon their visit for antenatal care. Women will be followed until 6 weeks after the time of delivery. Nested within this registry, the investigators will perform a registry-based adaptive cluster randomized crossover trial. The trial compares an experimental condition (echocardiographic screening) and a control condition (routine antenatal care).
In-hospital mortality after cardiac surgery ranges from 2-6%. Many patients suffer from major adverse cardiovascular events (MACE) which results in impaired disability-free survival. Troponin plays the central role in identifying MACE. However, interpretation after cardiac surgery is difficult due to ischemia-reperfusion-injury and direct surgical trauma. While the 4th universal definition of type 5 myocardial infarction uses the 10 x ULN as cut-off, >90% of patients after on-pump procedures exceed this cut-off. Clinical consequences are unclear. The dynamic of Copeptin and Heart-type fatty acid binding protein (H-FABP) concentrations starts very early, i.e. several hours before Troponin. The investigators plan a prospective multicenter cohort study to evaluate 1) the independent association between Copeptin and H-FABP with disability -free survival and MACE after cardiac surgery; 2) the predictive gain of their addition to the Euroscore II; 3) the independent association between H-FABP and acute kidney injury.
Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements is performed using a bioprosthesis1. Durability of surgical bioprostheses varies based on the patient's age at the moment of implantation, type and size etc2. TAVI has become the preferred treatment for degenerated aortic bioprostheses in elderly patients3. The median time since index surgical aortic valve replacement (SAVR) and for bioprosthetic valve degeneration is typically 8 - 10 years4-6. TAVI in this setting has proven to have equally favorable results as in native aortic valves7. Balloon expandable8 and self-expanding9 transcatheter heart valves (THV) can be used in a degenerated bioprosthesis and each have specific assets and limitations. TAVI in a failed bioprosthesis can cause coronary obstruction, THV migration, paravalvular leakage and prosthesis patient mismatch. The SAPIEN-3 / Ultra and EVOLUT R/Pro are the 2 most commonly used THV platforms in contemporary clinical practice including treatment of failing surgical aortic bioprostheses. Objective: To compare TAVI with EVOLUT R/Pro vs. SAPIEN-3 / Ultra in terms of device success. Study design: International multi-center randomized study with 1:1 randomization to TAVI with SAPIEN-3 / Ultra or Evolut R/Pro. Study population: 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) and selected for transfemoral TAVI by heart-team consensus. Investigational intervention: Transfemoral TAVI with SAPIEN-3 / Ultra or Evolut R/PRO Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by - Absence of procedural mortality AND - Correct positioning of a single prosthetic heart valve into the proper anatomical location AND - Intended performance of the prosthetic heart valve (no severe prosthesis- patient mismatch and mean aortic valve gradient < 20 mmHg or peak velocity < 3 m/s, AND no moderate or severe prosthetic valve regurgitation). Severe prosthesis patient mismatch is defined by effective orifice area (EOAi) ≤0.65 cm2/m2 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure or valve related problems.
The CASPER study is a prospective, international, multicenter registry which aims to evaluate the use of an algorithm for choosing the size of the prosthesis to be implanted in patients with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29) and Evolut® R 34.
Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients. A very promising technique with the potential benefits of dodging oral anticoagulation, foreign material, and suitable for patients with small aortic annuli and in infectious endocarditis. Performing hemodynamic evaluation, assess the clinical implementation and report preliminary results at follow up .
Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.
In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinic-directed warfarin management. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM.