Clinical Trials

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.

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

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

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 assess the safety and performance of the Caisson Interventional Transcatheter MitralValve Replacement (TMVR) system for the treatment of severe symptomatic MitralValve Regurgitation (MR).

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 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 the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥ 3+) or severe (≥ 4+), symptomatic, degenerative mitral regurgitation with prolapse or flail of the P2 leaflet segment, and who are determined to be at intermediate or high-risk for mitral valve surgical repair, as assessed by the multi-disciplinary heart team.

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 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.

The purpose of this study is to assess the technical and procedural success of the Innovalve TMVR system when used to treat adult patients with symptomatic moderate-severe and severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for a transfemoral catheterization with transseptal approach to the left atrium.

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 HARPOON System in the treatment of patients with severe degenerative mitral regurgitation.

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

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 this study is:

1. To assess whether corrective rhythm procedure during robotic mitral valve repair produce reliable long-term results.
2. To determine the incidence of new onset atrial fibrillation after robotic mitral valve repair.
3. To determine whether rhythm plays a role in long term valvular function.
4. As a secondary aim, we would like to study the outcomes of small subset of patients (10 patients) who underwent robotically assisted left atrial mass removal.
5. As a secondary aim, we also plan to look at our robotic patients and compare them to the conventional repair cohort to study the various echocardiographic parameters.

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 demonstrate the safety and effectiveness of the AVP III as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position.

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.

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.