Randomized Study to Evaluate the Efficacy of Fluvastatin on Inflammatory Markers in Patients With...
Aortic Valve StenosisAtherosclerosis and aortic stenosis share inflammatory etiopathogenic characteristics in common. We hypothesized that statins therapy would decrease inflammatory markers concentrations in patients with degenerative aortic stenosis and halt the haemodynamic progression of the disease.
Aortic Valve Replacement With Trifecta(TM)
Aortic Valve InsufficiencyRegurgitation3 moreThe purpose of this study is to confirm the clinical safety and effectiveness of the Trifecta valve.
Biomarkers and Mechanisms of Disease Progression and Outcome of Aortic Stenosis in Humans
Aortic StenosisImaging4 moreBiomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.
Addressing Undertreatment and Health Equity in Aortic Stenosis Using an Integrated EHR Platform...
Aortic Valve StenosisThis multi-center, prospective, cluster-randomized controlled trial will evaluate Mpirik automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Aortic Valve Replacement (AVR). This study will evaluate the impact of Mpirik automated notifications on: (1) AVR utilization (including time to AVR); and (2) multidisciplinary heart team clinic evaluation (including time to evaluation) for patients with definitive or possible severe AS on echocardiogram. These endpoints will also be examined within and between assigned groups according to race, ethnicity, sex, and geography. The primary question that will be answered: Do automated alerts sent to clinical providers decrease under-treatment of severe aortic stenosis? The study will compare the rate of clinical follow-up and aortic valve surgery in a control group (no alerts sent) to a treatment group (alerts sent to an appropriate care provider).
Outcome Prediction in Patients With Aortic Stenosis After TAVI
Aortic StenosisSevereThis study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation
Involvement of the Gut Microbiota in Calcified Aortic Stenosis
Aortic StenosisGastrointestinal Microbiome1 moreCalcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation. It is the most frequent cause of valve disease in the elderly. To date, no means of preventing the disease has been discovered, and the only treatment available is valve replacement during cardiac surgery, or percutaneous implantation of a valve prosthesis when the narrowing becomes severe and causes symptoms. The intestinal flora or microbiota, the reservoir of all the microorganisms in the gut, is implicated in numerous diseases, particularly of the intestine. But to date, no study has established a link between CAS and microbiota. The intestinal microbiota acts through molecules produced by itself or the host and passing into the bloodstream. In the pathophysiology of CAS, the valve leaflets are breached and do not heal. These molecules can enter and have beneficial or deleterious effects, in particular promoting calcification of aortic valve cells. Concrete objectives: Improve understanding of calcific aortic stenosis in humans Study the composition of intestinal flora in patients with aortic stenosis and compare it with healthy subjects Study the molecules in the intestinal flora likely to be involved in the development of aortic stenosis in humans.
VitaFlow® Transcatheter Aortic Valve Replacement System Pre-market Trial Long Term Follow Up (VITAL)...
Aortic Valve DiseaseAortic Valve StenosisThis study is an observational study to evaluate the long-term safety and effectiveness of the valve system.
Exercise Training After Transcatheter Aortic Valve Implantation
Aortic Valve StenosisTAVI2 moreIn this prospective, controlled trial, patient after TAVI will be randomized to either exercise training or usual care group.
FlexNav EU CE Mark Study
Symptomatic Severe Aortic StenosisThe purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Aortic Valve StenosisExpand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System