Clinical Trials

The purpose of this trial is to establish the safety and feasibility of the Edwards SAPIEN XT™and SAPIEN 3™ device and delivery systems in patients with severe symptomatic calcific mitral valve disease with severe mitral annular calcification who are not candidates for standard mitral valve surgery.

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.

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

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.