Active clinical trials for "Aortic Valve Stenosis"

The management of symptomatic patients with moderate Aortic Stenosis (AS) remains challenging and tests that would give more definitive answers are needed. The value of increase in Aortic Valve mean Gradient (AVMG), lack of change in Aortic Valve area (AVA) and calculation of valve compliance/resistance during stress echo (SE) in the symptomatic moderate AS population prognostication has to the investigators knowledge not been examined before. Similarly the additive value of myocardial blood flow reserve (MBFR), Computed Tomography (CT) calcium score, speckle tracking echocardiography, carotid ultrasonography, and N-Terminal pro B- type natriuretic peptide B (NT-proBNP) in the prognostication of this population group especially in combination with SE remains unclear.

Transcatheter aortic valve implantation (TAVI) has emerged as a valuable minimal-invasive treatment option in patients with symptomatic severe aortic valve (AV) stenosis at prohibitive or increased risk for conventional open-heart surgery. Recent randomized clinical trials reported a large treatment effect of TAVI over medical treatment among inoperable patients and similar or superior outcomes compared with surgical aortic valve replacement in high to intermediate risk patients. However, atrio-ventricular conduction disturbances and arrhythmias (in particular atrial fibrillation) before, during or after TAVI remain a matter of concern as they have important consequences. The objective of this study is to investigate the incidence, nature and prognostic significance of AV-conduction disturbances and arrhythmias among patients with severe, symptomatic aortic stenosis undergoing TAVI before, during and after the procedure using a small implantable cardiac monitoring system (ICM; Medtronic REVEAL LinQTM). One hundred patients will be enrolled in this study. Prior to TAVI (at least 4 weeks), at the time of preprocedural hemodynamic and anatomical assessment, the ICM will be inserted under the skin of the chest under local anesthesia. The device will be interrogated just prior to readmission for TAVI and thereafter at 1, 3, 6, and 12 months of follow-up. The incidence of symptomatic as well as silent brady- and tachyarrhythmias will be recorded, and its impact on medical and device treatment as well as clinical outcomes analyzed. The present study will provide information about the actual incidence and impact of symptomatic and silent arrhythmias and AV-conduction disturbances among patients with severe, symptomatic aortic stenosis undergoing TAVI. Specifically, the study estimate the burden of arrhythmias before TAVI and to accurately determine the incidence of new onset atrial fibrillation and complete AV-block within 12 months after the procedure. Identifying patients at risk for AV- conduction abnormalities, atrial fibrillation (AF), and non-sustained or sustained ventricular arrhythmias may guide future preventive measures, medical treatment and improve patients outcomes after TAVI.

Aortic stenosis is a major cause of morbidity around the world. Progressive aortic stenosis leads to cardiac hypertrophy as a compensatory response. A maladaptive response may lead to heart failure at varying degrees of severity of aortic stenosis in individual patients. The predicting factors for the occurrence of a maladaptive response are not well defined. Therefore current medical therapy for aortic stenosis is considered insufficient and may actually cause harm. The only effective therapy for severe, symptomatic aortic stenosis is aortic valve replacement. It has been found in an experimental study that Podocan determines the degree of cardiac hypertrophy in response to pressure overload via the Wnt-pathway. The possible prognostic role of secreted circulating Wnt modulators in aortic stenosis has also recently gained attention. This project will attempt to establish the prognostic role of circulatory Podocan and Wnt modulators for maladaptive left ventricular response to aortic stenosis. This may help identify patients at particular risk to develop left ventricular dysfunction with aortic stenosis and improve understanding of the mechanisms of left ventricular remodeling in aortic stenosis. Hence, this may also later act as an important background in finding more effective therapies to prevent or delay maladaptive left ventricular response in aortic stenosis.

This is an international, mutli-center, prospective, consecutively enrolled, observational registry. 2000 patients are planned to be enrolled over one year at up to 150 participating sites. 300 patients out of the 2000 patients enrolled in the main registry are planned to be consecutively enrolled in a select few sites for studying the valve performance. Echocardiogram and angiogram will be taken routinely.

Current care randomized clinical trial comparing the CE marked Symetis ACURATE neo™ Aortic Bioprosthesis and ACURATE TF™ Transfemoral Delivery System with the CE marked Medtronic CoreValve Evolut R TAVI system (or any future CE-marked CoreValve versions).

Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.

Background: Computed tomography (CT) creates three-dimensional images based on X-ray imaging. CT is useful for determining treatment approaches for certain diseases, such as calcific aortic stenosis (narrowing of the aorta because of calcium deposits). Comparing the data received from CT scans with the data received from heart catheterization (which assesses the heart's condition and function) can be used to improve treatment in patients with certain heart conditions. Researchers are interested in looking at the effectiveness of both procedures in assessing possible surgical treatments for patients with calcific aortic stenosis. Objectives: - To analyze cardiac CT scans in conjunction with existing heart scan results to improve treatments for future minimally invasive aortic valve replacement. Eligibility: - Patients 18 years of age and older who have been diagnosed with aortic valve stenosis that may be treated surgically, and who will undergo or have recently undergone heart catheterization. Design: Participants will have a CT scan within 90 days of the medically necessary heart catheterization, but before any other surgical or catheter treatment. During the CT scan, patients will be asked to hold their breath intermittently for about 5 to 20 seconds. Patients will be inside the scanner for less than 30 minutes. Patients will be asked to return in 3 to 7 days for a blood test to check kidney function. Researchers will analyze the results of the CT scan in conjunction with the previous results from the catheterization to determine possible improved treatment options.

To create a registry of all Oregon children undergoing surgical repair of congenital heart disease since 1958 in order to determine mortality, morbidity, and disability after surgery and to assess the safety of pregnancy in women with corrected congenital heart disease and the risk of prematurity and occurrence of congenital heart defects in offspring.

Prospective, multicenter registry in patients undergoing commercially available balloon expandable valve implantation. The registry will consist of 3 phases: Prospective determination of baseline Status Quo (3 months): Documentation of treatment pathways and endpoints of "routine" patients without educational program Dedicated reflection and training (1 day): One training session after the observational period to reflect on treatment pathways, exchange between valve coordinators involved, and develop improvements. Implementation of tailored changes (2 months): Implementation of the changes developed in the training. Determination of the effect (3 months): Coordinator measures optimization changes and determines effects.

Until a few years ago the only interventional option available for severe aortic stenosis was surgical aortic valve replacement. About a decade ago, a novel percutaneous technique was applied for the first time in humans, the transcatheter aortic valve implantation (TAVI). Initially this procedure was reserved for those patients deemed too high risk for surgical intervention. As technology progressed in this domain, the indication for TAVI expanded to a broader population of patient with severe aortic stenosis. To-date there are no long-term data for mortality and this is the central question this study will explore in correlation with haemodynamic parameters. Essentially, this study will explore the effect of TAVI in the long term. All patients that had a TAVI within the RBH&HH NHS Foundation Trust between January 2008 and December 2017 will be included in the study. This is a retrospective study.