An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral...
Functional Mitral RegurgitationAtrial Fibrillation1 moreThe objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)
V-Chordal Adjustable System for Chordal Replacement in Mitral Valve Insufficiency Due to Leaflet...
Mitral Leaflet ProlapseThe V-Chordal System is a new technology for mitral repair. The Valtech V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae "off-pump" to achieve an optimal coaptation. The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords.
Twelve Transcatheter Mitral Valve Replacement (TMVR) Pilot Study
Mitral Valve InsufficiencyStudy to evaluate the safety and performance of the Twelve TMVR System
A Clinical Study of the CardiAQ™ TMVI System (Transapical DS)
Mitral InsufficiencyHeart Valve Disease2 moreThe purpose of the study is to evaluate the initial short and long-term safety and performance of the CardiAQ™ Transcatheter Mitral Valve Implantation System using the Transapical Delivery System. The study will enroll patients with moderate to severe mitral valve regurgitation who are considered high or extreme risk for mortality and morbidity from conventional open heart surgery.
A Randomized Study of the MitraClip Device in Heart Failure Patients With Clinically Significant...
Cardiovascular DiseasesThis trial is a randomized study of the MitraClip device in heart failure patients with clinically significant functional mitral regurgitation. A hierarchical composite of all-cause mortality and recurrent heart failure hospitalizations is hypothesized to occur at a lower rate with the use of the MitraClip device in addition to optimal standard medical therapy compared to optimal standard of care therapy alone.
Prognosis in Asymptomatic Mitral Regurgitation (PAMIR) Study
Mitral RegurgitationThe purpose of this study is to determine if the use of BNP/NT-proBNP levels in the detection of early left ventricular dysfunction and damage may improve the timing of cardiac surgery and therefore the long-term management of asymptomatic patients with severe mitral regurgitation.
Using Beta Blockers to Treat Mitral Regurgitation
Heart DiseaseMitral Regurgitation2 moreThe purpose of this study tests whether beta-blocker will benefit asymptomatic patients with chronic primary mitral regurgitation.
Safety and Performance Study of the Harpoon Mitral Valve Repair System
Mitral Valve RegurgitationMitral Valve Prolapse1 moreThe primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
Mitral RegurgitationTo evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant...
Mitral Valve InsufficiencyHeart FailureMitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the heart. Improper functioning of the mitral valve disrupts the proper flow of blood through the body, resulting in shortness of breath and fatigue. When mild, MR may not pose a significant danger to a person's health, but severe MR may be associated with serious complications, such as heart failure, irregular heart rhythm, and high blood pressure. Although there are treatments for MR, including medication and surgery, more information is needed on the effectiveness of these treatments in people with significant MR. This study will compare the safety and effectiveness of corrective surgery added to optimal medical treatment (OMT) versus OMT alone in treating people with significant MR caused by an enlarged heart.