Active clinical trials for "Aortic Valve Stenosis"

In this study, the investigators aim to compare cerebral embolic load in patients undergoing surgical aortic valve replacement using either the minimized extracorporeal circulation or the conventional extracorporeal circulation technique. The detection of cerebral emboli is performed not-invasively by transcranial Doppler detection of high-intensity transient signals representing solid or gaseous microembolism in the middle cerebral arteries. The investigators hope to get more insight in the mechanism (incl. quantity) of cerebral embolism during aortic valve surgery using extracorporeal circulation.

Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.

The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).

The purpose of this study is to determine that Transcatheter aortic valve replacement (TAVR) with SAPIEN 3 is superior to traditional surgical aortic valve replacement(SAVR) with bio-prosthesis regarding the rate of all-cause mortality at 1 year in patients with symptomatic severe aortic valve stenosis.

It is a common understanding that patients with coronary heart disease are suffering, among others, from reduced myocardial perfusion. In order to increase (normalize) the reduced perfusion, when a conventional approach failed, coronary bypass surgery, coronary vessel dilatation or stenting are performed. The similar situation with reduced myocardial perfusion may be found in patients with stenosis of the aortic valve, where aortic valve replacement may increase myocardial perfusion by left-ventricular remodelling. However, there is presently no method established to measure myocardial perfusion quantitatively and noninvasively before and after a therapeutic intervention. Data of pre- and post-therapeutic myocardial perfusion, quantitatively measured in ml/100g/min would strengthen the indication for specific therapeutic approach and enable an objective control of effectiveness of the applied therapy. Hypothesis: There is a measureable difference in quantitative myocardial perfusion values before (lower) and after (higher) interventional or surgical procedure. The goal of the study is to measure myocardial perfusion by advanced CT technology (e.g. iCT 256 Brilliance ) quantitatively in ml/100g/min in three groups of patients: Before and after coronary bypass surgery Before and after coronary vessel dilatation/stenting Before and after aortic valve replacement. The investigators will not assign specific interventions to the subjects of these three groups. Therefore, the research is strictly observational. Design: Prospective study to measure quantitatively myocardial perfusion in the above mentioned three groups of patients with simultaneous control and registration of all essential, physiological determinants of myocardial perfusion immediately prior to each CT study. The CT myocardial perfusion measurements will be performed directly after the indication for intervention or surgery and on the last day before discharge from hospital. All the collected data (determinants) inclusively the CT-studies will be anonymised and archived on a local server. The investigators of the University of Medical Computed Sciences and Technology, Innsbruck / Austria will perform the evaluation of the myocardial perfusion measurements and all statistical analysis independently of the CT-studies performing physicians.

To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.

To evaluate the effect on cognitive function, recovery, cardioprotection and haemodynamics of standard Remifentanil anaesthesia to standard Sufentanil anaesthesia in patients undergoing coronary artery bypass with or without aortic valve replacement.

The purpose of this study is to: Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV hypertrophy, and changes in LV systolic and diastolic function) after aortic valve replacement for severe aortic stenosis (AS) between three clinically available aortic valve bioprosthesis.

Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).

Aortic stenosis (AS) is the most frequent valvular heart disease in Western countries, with increasing prevalence. Recent guidelines recommend aortic valve intervention (surgical aortic valve replacement [SAVR] or transcatheter aortic valve replacement [TAVR]) in severe AS, as soon as symptoms or left ventricular (LV) dysfunction occur, in order to improve clinical outcome and achieve LV mass (LVM) regression. The highest amount of LVM regression is obtained during the first year. Nevertheless, there is heterogeneity in LV remodeling and residual LV hypertrophy is associated with poorer postoperative improvement in cardiac function and morphology. Incomplete regression of LV hypertrophy at 12 months after SAVR is a powerful predictor of adverse outcome. Yet, the use of specific pharmacological therapy to improve postoperative LVM regression could be an appealing therapeutic option after aortic valve intervention. Renin-angiotensin-aldosterone system blockers (RAASb) and more particularly angiotensin-II receptor blockers (ARBs) are efficient in reducing LVM in hypertensive patients, as emphasized by several meta-analyses. In addition, ARBs improve myocardial relaxation, diastolic function, decreased hypertrophy and may have anti-fibrotic effects. In a recent retrospective study from our group, RAASb prescription after SAVR was associated with increased survival, but confirmation through a randomized trial is mandatory. In a prospective randomized single-center study, the use of candesartan was associated both with LV and LA remodeling as compared to the conventional management. Nevertheless, these results are based on echocardiographic data, which is not the gold standard for the assessment cardiac remodeling, and no placebo or active comparator was tested to control the impact of ARBs in these patients. The primary objective of this Phase II study is to investigate the efficacy of valsartan, introduced postoperatively, as compared to placebo, on 1-year changes in indexed LVM, as assessed by CMR, in patients undergoing aortic valve intervention (SAVR or TAVR) for AS. The secondary objectives are to compare the efficacy of valsartan vs. placebo in terms of one-year changes (difference from baseline) in cardiac function and in cardiac morphology, one-year exercise capacity and one-year changes in biomarkers related to cardiac function. In addition, the assessment of the safety of valsartan will also be considered as secondary objective. The ARISTOTE trial is a multicenter prospective phase II, randomized, double-blind study including patients with the diagnosis of severe AS and indication for valve intervention. The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist. Patients will be randomized between 2 groups (valsartan versus placebo) and the treatment will be initiated (80 mg daily) at 5±4 days following aortic valve intervention. The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group. The patients will be cautiously monitored and any adverse events will be collected. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study. The tolerance will be regularly assessed and dose adjusted according to a pre-specified algorithm.