Aortic valve stenosis

Displaying 39 studies

  • A Study Comparing Muscle Tissue Removal versus Just Membrane Removal on the Long Term Recurrence of Discrete Subaortic Stenosis Rochester, MN

    The purpose of this study is to compare the addition of muscle tissue removal versus membrane removal alone in patients with discrete subaortic stenosis to assess the long term rate of repeat left ventricle outflow obstruction.

  • A Study to Evaluate the Neuro-embolic Consequences of TAVR Rochester, MN

    A prospective, multi-center study to evaluate the neuro-embolic consequences of Transcatheter Aortic Valve Replacement (TAVR)

  • Left Ventricular Remodeling and Echocardiographic Predictors of Mortality in Severe Aortic Stenosis Rochester, MN

    The purpose of this study is to compare 3D measurements to conventional 2D measurements of left ventricular size and mass, left ventricular systolic function, and left ventricular diastolic function in patients with severe aortic stenosis and determine whether there are significant differences in remodeling between men and women and in those with and without a history of hypertension. The study will also aim to identify echocardiographic markers associated with NYHA symptom class, risk of atrial fibrillation, the need for aortic valve operation, or cardiac death or persistent heart failure after aortic valve replacement for severe aortic stenosis.

  • A Study of the Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients with Aortic Stenosis Rochester, MN

    The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve in patients who have  severe, symptomatic aortic stenosis and are at low operative risk for standard aortic valve replacement.

  • The Partner II Trial: A Study of the Placement of Aortic Transcatheter Valves Rochester, MN

    The purpose of this trial is to determine the safety and effectiveness of the Edwards SAPIEN XT and the Edwards SAPIEN 3 transcatheter heart valve and delivery systems which are intended for use in patients with symptomatic, calcific, severe aortic stenosis.

  • Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement Rochester, MN

    The objective of this study is to evaluate the safety and effectiveness of the Lotus™ Valve System and LOTUS Edge™ Valve System for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at extreme or high risk for surgical valve replacement.

  • A Study of Patients Diagnosed with Severe Aortic Stenosis having a Measurable Change in Heart Function Using a New Technique (3D echocardiographic strain) Compared to Controls Rochester, MN

    The purpose of this study is to determine whether patients diagnosed with severe aortic stenosis have a measurable change in heart function as measured by a new technique (3D echocardiographic strain) compared to controls and to determine whether they show a significant improvement in heart function (as measured by 3D strain) during intermediate-term follow up after aortic valve replacement.

  • A Study of the Impact of Frailty on Health Outcomes following Aortic Valve Replacement Rochester, MN

    The purpose of this study is to determine what factors predict poor surgical outcomes, and the extent to which patient-centered outcomes differ between participants deemed frail and non-frail.

  • Safety of Ataciguat in Patients with Moderate Calcific Aortic Valve Stenosis Rochester, MN

    This study will determine whether Ataciguat (HMR1766) is well-tolerated in patients with mild to moderate calcific aortic valve stenosis. The primary focus of these studies will be on changes in blood pressure and orthostatic tolerance (i.e., ability to stand up without passing out), and determining whether treatment with Ataciguat results in significant reductions in blood pressure in this patient population.

  • Assessment of Myocardial Tissue Damage in Aortic Stenosis Scottsdale/Phoenix, AZ

    Aortic stenosis (AS) is the most common valve disease in the United States and most common indication for valve replacement surgery. Anatomical and hemodynamic severity of AS is insufficient for elucidating patients' prognosis. Therefore, the decision about the optimal timing of surgical intervention remains critical. However, the changes in structure and electrical activity of the cardiac muscle can be assessed by noninvasive imaging and electrocardiography (ECG). Degenerative myocardial changes characterized by fibrosis or collagen deposits are frequently observed in AS patients and have a negative impact on patient outcomes. In this project, our objective is to determine whether echocardiographic image ...

  • The PARTNER 3 - AVIV Trial Rochester, MN

    To assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing aortic bioprosthetic valve.

  • Collection of Blood and Tissue in Patients with Aortic Stenosis Scottsdale/Phoenix, AZ

    The goal of this study is to create a comprehensive system of blood and tissue banking of samples from Mayo Clinic Arizona patients with a clinical diagnosis of aortic stenosis who are either undergoing routine care at Mayo Clinic or undergoing aortic valve surgery.  The tissue samples will be used for future research of aortic stenosis at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.

  • A Study of Information Provided by Cardiopulmonary Exercise Testing When Evaluating Patients with Aortic Stenosis Rochester, MN

    The purpose of this study is to find if cardiopulmonary exercise testing data will provide any predictive information in evaluating patients with aortic stenosis for severity, symptoms and surgical risk.

  • Multicenter Prospective Study of Low-Flow Low-Gradient Aortic Stenosis (TOPAS Study) Rochester, MN

    Low-flow, low-gradient (LF-LG) aortic stenosis (AS) may occur with depressed (i.e. Classical LF; CLF) or preserved (i.e. Paradoxical LF; PLF) LV ejection fraction (LVEF) and both situations are amongst the most challenging encountered in patients with valvular heart disease. Although, CLF-LG AS is recognized has an important clinical entity, current ACC/AHA-ESC guidelines however do not provide precise recommendations for clinical management of these patients . PLF-LG AS is a new entity recently described by our group, which is characterized by more pronounced LV concentric remodeling with smaller LV cavity size and a restrictive physiology leading to impaired LV filling, altered ...

  • PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban Rochester, MN

    The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.  Currently, warfarin is the only approved anticoagulation for patients with mechanical valves.

  • Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI). Rochester, MN

    The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with sever symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

  • Pericardial Resection to Treat Heart Failure Rochester, MN

    The researchers are doing this study to find out whether there will be less increase in cardiac filling pressure after the surgeon opens the pericardium (the membrane around the heart) than when the pericardium is intact. The researchers want to see whether opening the pericardium is an effective way to reduce the blood filling pressures in the heart.

  • A Study of Aortic Valve Gradient Severity in Patients with Atrial Fibrillation Rochester, MN

    The purpose of this study is to examine if the measurements that we make by current standards for patients with both aortic stenosis (narrowed aortic valve) and atrial fibrillation underestimate severity of aortic stenosis and if that has any effect on timing of aortic valve surgery

  • Comprehensive Imaging and Biomarker Assessment of Aortic Valve Stenosis Rochester, MN

    The purpose of this study is detection of relationship between biomarkers and the severity of AS (echocardiographic hemodynamics/CT-calcium load).  Detection of relationship between biomarkers to the consequences of AS on the LV (echo remodeling parameters and speckle-tracking LV strain).  Detection of differences on echocardiographic and CT-calcium load AS severity assessments between tricuspid and bicuspid valves.  Detection of biomarker associations with AS hemodynamics, CT-calcium load, LV remodeling and LV strain between tricuspid and bicuspid phenotypes. 

  • Mild to Moderate Calcified Aortic Stenosis Registry Rochester, MN

    The purpose of this study is to identify and follow a population of mild to moderate aortic stenosis patient to assess the natural history of aortic stenosis in the 2010’s. 

  • A Study of Cardiac Ultrasound Obtained Prior to Surgery can Provide us with Additional Information in Patients with Severe Aortic Stenosis and Poor Left Ventricular Function Rochester, MN

    The purpose of the study is to investigate new cardiac ultrasound methods (2D- Speckle echocardiography) to evaluate myocardial mechanical properties in images obtained prior to surgery, and if this can provide us with additional prognostic information.

  • A Study to Assess Aortic Valve Severity in Patients with Atrial Fibrillation Pre and Post Cardioversion Rochester, MN

    The purpose of this study is to determine if aortic valve stenosis severity is underestimated in patients with a diagnosis of atrial fibrillation and aortic stenosis who are scheduled for cardioversion.

  • Clinical and Imaging Factors Associated with Symptoms in Patients with Severe Aortic Stenosis Rochester, MN

    The aim of this study is to reveal differences between symptomatic and asymptomatic severe AS patients matched for anatomic (aortic valve area) and hemodynamic (mean gradient) AS severity. The secondary aim is to evaluate functional and prognostic significance of strain value of LV and RV.

  • Cardiac Vascular Reconstruction DynaCT for TAVI Procedures Rochester, MN

    The purpose of this work is to evaluate the feasibility of a new Cardiac Vascular Reconstruction (CAVAREC, Siemens Medical Systems, Germany) image reconstruction algorithm for use during transcatheter aortic valve implant (TAVI) procedures. CAVAREC utilizes the same x-ray projection images as currently acquired for clinical DynaCT. X-ray image acquisition to allow CAVAREC will occur during the TAVI procedure both before and after the TAVI device is implanted. The CAVAREC image processing algorithm will be implemented on an off-line workstation after the TAVI procedure is complete. After the TAVI procedure, CAVAREC images will be quantitatively and qualitatively compared to Siemens DynaCT ...

  • Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Rochester, MN

    The purpose of this study is to evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at High Risk for aortic valve replacement surgery.

  • PROTECTED TAVR: Stroke PROTECTion With SEntinel During Transcatheter Aortic Valve Replacement Rochester, MN

    The purpose of this study is to demonstrate that use of the Sentinel® Cerebral Protection System significantly reduces the risk of peri-procedural stroke (≤ 72 hours) after transcatheter aortic valve replacement (TAVR).

  • Invasive Hemodynamic Response in Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement Rochester, MN

    The purpose of this study is to compare the hemodynamic effects of Low Flow versus Normal Flow Aortic Stenosis after Transcatheter Aortic Valve Replacement.

  • A Study Evaluating the Effects of Ataciguat (HMR1766) on Aortic Valve Calcification Rochester, MN

    The primary objective of the current study is to determine whether Ataciguat (HMR1766) slows progression of valve calcification in patients with moderate calcific aortic valve stenosis. Secondary and tertiary objectives are to determine whether Ataciguat slows progression of aortic valve function, reduces systemic inflammation, and prevents left ventricular dysfunction in patients with moderate calcific aortic valve stenosis.

  • A Study of Strain Echocardiography in Assessment of Valvular Heart Disease Rochester, MN

    Classical echocardiographic assessment of heart valves is critical in determination of disease severity. However, echocardiography has only limited ability to predict how well an individual patient will do at time of surgery. New echocardiographic technology allows us to measure new, more refined parameters of your heart’s performance. This study is investigating whether these new parameters are better in predicting outcomes.

  • Left Ventricular Remodeling Post-TAVR Rochester, MN

    There has been a paradoxical finding in clinical trials with severe AS patients that LV mass regression is greater and faster after surgical AVR compared to transcatheter AVR while hemodynamic profile is better after TAVR compared to SAVR. We do have a preliminary finding to explain this paradox and want to validate it.

  • Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) Rochester, MN

    The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

  • The Effects of Aortic Valve Replacement on Sleep Disordered Breathing, Heart Rate Variability and Ventricular Ectopy Burden in Patients with Severe Aortic Stenosis Rochester, MN

    Our overall goal is to determine whether the AVR improves SDB where present and sleep profiles (including sleepiness symptoms, quality of life and hypoxia).

  • Prevalence of Transthyretin Cardiac Amyloidosis in Clinically Significant Aortic Stenosis Rochester, MN

    The purpose of this study is to determine the prevalence of TTR-CA in a community-based cohort of moderate and severe aortic stenosis patients using 99mTc-PYP single-photon positive emission computed tomography with computed tomography (SPECT/CT).

  • A Study of Long Term Outcomes of Patients who have had Open Valvotomy for Congenital Aortic Valve Stenosis Rochester, MN

    The purpose of this study is to evaluate the outcomes of surgical Aortic Valvotomy for congenital aortic stenosis.

  • Usefulness of Computed Tomography in Aortic Stenosis Rochester, MN

    Aims, purpose, or objectives: Evaluate the use and interest of computed tomography as a new tool in Aortic Stenosis evaluation and risk stratification. The objective is to evaluate the impact of new computed tomography indices (global calcification, localized calcification, anatomic measurements…) in aortic stenosis management.

  • Left Ventricular Ejection Hemodynamics in Patients with Hypertrophic Cardiomyopathy and Valvular Aortic Stenosis Rochester, MN

    The purpose of this study is to compare ejection hemodynamics in patients with obstructive hypertrophic cardiomyopathy (HCM) before and after septal myectomy.

  • Evaluation of Transcatheter Aortic Valve Replacement Compared to SurveilLance for Patients With AsYmptomatic Severe Aortic Stenosis Rochester, MN

    This clinical trial is a prospective, randomized, controlled, multi-center study. Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 THV or clinical surveillance. Patients will be stratified by whether or not they are able to perform a treadmill stress test. Patients who have a positive stress test will be followed in a registry to collect data on subsequent treatment and mortality, as applicable.

  • Biomarkers in Aortic Stenosis - B.A.S.S. Jacksonville, FL; Rochester, MN

    This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the blood tests will be compared to the information from the clinically-indicated echocardiogram and one blood test compared to another.

  • A Study to Evaluate a Computerized Stethoscope called ©CompuSteth to Diagnose Heart Disease Rochester, MN

    The purpose of this study is to identify patients presenting to the echocardiogram laboratroy for routine clinically indicated echocardiography or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures. These patients will undergo a cardiac physical examination using the ©CompuSteth stethoscope for the following 2 aims:

    1) Collect computerized auscultation data to train the ©CompuSteth device on how a variety of cardiac pathologies "sound", including normal heart sounds, aortic stenosis, and mitral valve disease, after identifying these cardiac pathologies using gold-standard testing with echocardiography or invasive cardiac catheterization.

    2)Prospectively determine the accuracy of the ©CompuSteth device as a tool to non-invasively ...

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