Clinical Trials

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.

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.

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.

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

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.

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.

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.

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.

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.

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 ...

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

The purpose of this study is to determine the performance of AI-ECG as a screening tool in clinical practice identifying patients with moderate or severe AS, to determine the ability of POCUS in detecting moderate or severe AS amongst in patients with positive AI-ECG.

Additionally, to identify which clinical features (presence of cardiac murmur, prevalence of hypertension, age or sex) can improve decision making process of applying echocardiography exam in patients with positive AI-ECG.

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.

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 ...

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.

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.

The purpose of this study is to evaluate the effectiveness and safety of DA-1229 compared to placebo in patients with calcific aortic valve disease with mild to moderate aortic stenosis. There are 3 arms in this study to which patients will be randomized in a ratio of 1:1:1 to receive the DA-1229 or placebo orally once daily for a period of 104 weeks. The 3 arms are: placebo, DA-1229 5mg Group, and DA-1229 10 mg Group. The study will have three phases: Screening Period (up to 4 weeks), Treatment Period (104 weeks), and Follow-Up Period (2-4 weeks). Total Study Duration is ...

The purpose of this study is to obtain safety and effectiveness data to support indication expansion for the Medtronic transcatheter aortic valve replacement (TAVR) System to include patients with moderate, symptomatic Aortic Stenosis (AS).

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.

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

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.

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.

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. 

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. 

The purpose of this trial is to generate clinical evidence on valve safety and performance of self-expanding (SE) versus balloon-expandable (BE) transcatheter aortic valve replacement (TAVR) in subjects with a small aortic annulus and symptomatic severe native aortic stenosis.

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

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 ...

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

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.

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.

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.

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.

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.

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

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).

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.

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.

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

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

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.

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.

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 ( VoqX) stethoscope for the following 2 aims:

1) Collect computerized auscultation data to train the ©VoqX 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 ©VoqX device as a tool to non-invasively screen for ...

This study (SE2030) will establish a platform of data to build the perfect stress echo test, suitable for all patients, anywhere, anytime, also quantitative and operator independent.