Active clinical trials for "Aortic Valve Stenosis"

Evaluation of TAVR using the NAVITOR valve in a Global Investigation.

The goal of this clinical trial is to learn about the safety and performance of the F2 device for cerebral embolic protection in participants with symptomatic aortic stenosis undergoing a Transcatheter Aortic Valve replacement procedure. Participants will complete several neurocognitive assessments and an MRI procedure.

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: Strict BP control for 12 months reduces the progression of LV remodelling compared to conventional treatment. Strict BP control for 2 years reduces the increase in aortic valve calcification and LV remodelling compared to conventional treatment. Strict BP reduction for up to 10 years reduces the need for aortic valve replacement and cardiovascular events compared to conventional care.

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).

Iron deficiency is common among patients undergoing TAVI. It is estimated at 54-79%. Previous non-randomized small trial have shown symptomatic benefit in treating iron deficiency in this group of patients. The investigators predict, that as IV iron will improve symptoms, quality of life and exercise tolerance in this group of patients.

This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.

The primary objective of this study is to compare, in patients with severe aortic stenosis and concomitant coronary artery disease accepted for transcatheter aortic valve implantation (TAVI) and percutaneous coronary intervention (PCI) by the multidisciplinary Heart Team, the safety and efficacy of instantaneous wave-free ratio (iwFR)-guided complete revascularization performed after (within 1-45 days) with iwFR-guided complete revascularization performed before (within 1-45 days) TAVI using the Edwards SAPIEN Transcatheter Heart Valve®.

MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive Extracorporeal Technologies International Society (MiECTiS). It is designed to ultimately address the emerging effectiveness of MiECC systems in the light of modern perfusion practice worldwide. The primary hypothesis is that MiECC, as compared to conventional CPB (cCPB), reduces the proportion of patients experiencing serious perfusion-related postoperative morbidity after cardiac surgery. The study will be led by the Clinical Research Unit of the Special Unit for Biomedical Research and Education (SUBRE), Aristotle University of Thessaloniki School of Medicine in Greece (AUSoM) with Chief Investigator Professor Kyriakos Anastasiadis, who is a key-opinion-leader in the field of MiECC, founder and Executive Board of MiECTiS.

Calcific Aortic Stenosis (CAS) can cause severe adverse cardiac events, but there is currently no effective drug that can prevent or delay the progression of the disease, aortic valve replacement is still the only therapy. The epidemiology of CAS shows that it is related with level of Lp(a)、LDL-C and PCSK9. Several observational studies indicate that the use of statins to decrease the level of LDL-C is associated with the reduced incidence of CAS, but no Randomized Control Trials(RCTs) show that statins have any benefit on the progression or clinical outcome of CAS，so the investigators speculated that this may be related to the limited reduction of LDL-C by statins therapy. The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor has emerged as a new lipid-lowing drug. On the basis of statin treatment, it can further reduces LDL-C and Lp(a) concentrations by 50% to 60% and 20% to 30%,respectively. Some studies report that elevated plasma PCSK9 levels are related to CAS and PCSK9 R46L loss-of-function mutation are associated with lower rates of CAS, and other observational studies found that PCSK9 inhibitors can reduce the incidence of CAS. The research, on the basis of statins therapy, intends to study the effect of PCSK9 inhibitors on delaying or preventing patients with CAS. A total of 160 patients are planned to be selected for the presence of CAS that are confirmed by echocardiography but currently do not need valve replacement, and with the diagnosis of hypercholesterolemia. All of the patients were followed at 4 weeks、24 weeks 、48 weeks and 96 weeks for a minimum of 2 years. The primary endpoint is the average annual change in aortic-jet velocity. Secondary endpoints include average annual change of aortic valve calcification score that measured by Computed Tomography and major adverse cardiovascular events (cardiovascular death, non-fatal stroke or non-fatal myocardial infarction). The outcomes of the study will provide new ideas for the treatment of patients with CAS, and will also provide an important theoretical basis for the expansion of the clinical indications of PCSK9 inhibitors and the exploration their extra-lipid-lowering effects.

The aim of the present study is to investigate safety and efficacy of early versus deferred aortic valve replacement in patients with moderate aortic stenosis combined with moderate mitral regurgitation.