Clinical Trials

The purpose of this study is to compare the value and practicality of using 3D color doppler echocardiography of the vena contracta area versus the standard 2D method when needing accurate measurement of mitral valve regurgitation.

The purpose of this study is to investigate post-operative changes in cardiac structure and function for patients with mitral regurgitation to define heart remodeling.

The purpose of the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects.

We hypothesize that (1) Patients with significant left atrial pressure (LAP) reduction during transcatheter mitral valve repair (TMVR) have lower cardiac output, more advanced diastolic dysfunction, increased left atrial stiffness, abnormal pulmonary vascular function and higher arterial afterload compared to TMVR patients without a significant LAP reduction. (2) TMVR and associated reduction in mitral regurgitation and LAP results in relief of pulmonary vascular congestion, and improvement in pulmonary vascular and right ventricular function.

Measure by Doppler color automated integration cardiac stroke volumes and calculate regurgitant volume.

Study to evaluate the safety and performance of the INNOVALVE system

The purpose of this study is to evaluate the safety and effectiveness of the Tendyne™ Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

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 Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) Trial is to confirm the safety and effectiveness of the MitraClip System for the treatment of moderate-to-severe or severe functional mitral regurgitation (FMR) in Symptomatic Heart Failure Subjects who are treated per standard of care and who have been determined by the site's local heart team as not appropriate for mitral valve surgery. This randomized controlled trial will provide the opportunity to strengthen or add labeling claims regarding safety and clinical benefits of the MitraClip System for symptomatic heart ...

The purpose of this study is to compare outcomes of MitraClip vs open mitral valve repair in patients with severe mitral regurgitation (MR) due to mitral valve prolapse (MVP) in those who have already undergone a previous open heart surgery.

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.

A prospective, open-label, and multi-centered feasibility registry.

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.