Clinical Trials

The purpose of this study is to elucidate the genetic basis of aBiMVP in hopes of determining novel mechanisms that underlie aBiMVP pathogenesis.

This investigation constitutes a feasibility study involving assessing the safety and feasibility of combining clinically indicated Left Atrial Appendage Occlusion (LAAO) and Transcatheter Mitral Valve Repair (TMVR) in one setting using approved devices.

The purpose of this study is to examine and characterize long term outcomes of patients who underwent Melody Valve in Valve procedure.

The purpose of this study is to establish the safety and effectiveness of the SAPIEN M3 System in subjects with mitral regurgitation (MR) who are at high surgical risk.

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.

Study to evaluate the safety and performance of the INNOVALVE system

The purpose of this study is to test the hypothesis that Endothelial Progenitor Cells osteoblastic phenotype (EPC-OCNs) play a significant role in the process of Mitral Annular Calcification (MAC) as prognostic markers of calcific cardiac valves.

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.

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.

The purpose of this study is to assess the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve in patients with a failing mitral bioprosthetic valve.

The purpose of this study is to enroll high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.

The purpose of this study is to evaluate the safety and effectiveness of the HARPOON System in the treatment of patients with severe degenerative mitral regurgitation.

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.

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

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.

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 this study is to determine long term vital status, symptoms, and need for repeat procedure after alcohol septal ablation, to determine patient and procedural factors associated with successful alcohol septal ablation and need for repeat procedure, and to determine the impact of conduction abnormalities after alcohol septal ablation on long-term outcomes.

The purpose of this study is to determine if 3D volumetric measurements will allow more robust quantification of valvular heart disease severity.

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.