Mitral Valve Regurgitation

Researchers are evaluating the ReValve System as a treatment option for people with clinically significant mitral regurgitation who are suitable candidates for mitral valve surgery. This clinical study focuses on replacing the native mitral valve using this device, aiming to assess its technical success during the procedure. The study is in its early phase and sponsored by ReValve Solutions Inc. Participants will receive the ReValve System, a device designed to replace the mitral valve. This is a single-arm study where all participants undergo the investigational procedure with the device. There are no comparison groups or placebos involved. During the study, participants will be monitored for the technical success of the procedure. Assessments may include heart function tests such as echocardiograms and other cardiac imaging to evaluate valve performance. The study will continue until January 2028, with follow-up planned to understand the outcomes of the valve replacement.

Researchers are evaluating the GeminiOne Transcatheter Edge-to-Edge Repair (TEER) System for adults with severe, symptomatic mitral regurgitation (MR). This multi-center, non-randomized clinical trial aims to confirm the safety and effectiveness of the device in patients who are at high risk for surgical intervention or have not responded to other therapies. The study is sponsored by Sierra Valve LLC and involves participants from centers in the United States, Canada, and Europe. Participants will receive the investigational GeminiOne TEER System, which includes a clip implant made from specialized alloys and a delivery system designed for left atrial placement through transfemoral trans-septal access. Up to 15 subjects will be treated initially, and the study will last about 72 months with a 12-month enrollment period. After implantation, participants will be followed for 60 months to monitor outcomes. During the study, participants will undergo assessments including echocardiography, functional status evaluation, and quality of life questionnaires at 30 days, 12 months, and annually thereafter. Researchers will track major adverse events, mortality, stroke, rehospitalizations, and changes in heart function and symptoms. Safety and procedural success will be monitored closely during the first 30 days post-implant, with continued evaluation throughout the follow-up period.

This research aims to better understand mitral and tricuspid valve leakage (regurgitation) in patients diagnosed with transthyretin amyloid cardiomyopathy (ATTR-CM). It focuses on measuring how common these valve problems are, their severity, and how they affect patient outcomes. The study also seeks to create new standards for grading this leakage that fit the unique heart function changes seen in ATTR-CM, improving on current methods that do not account for this specific condition. As an observational study, it will gather detailed heart ultrasound (echocardiographic) data from patients with ATTR-CM, focusing on quantitative and semi-quantitative measures of mitral and tricuspid regurgitation. There are no experimental treatments; instead, the study collects information to better define and predict the impact of valve leakage in this condition. The research is conducted internationally across multiple centers, starting in 2025. Participants will undergo comprehensive baseline heart ultrasound assessments within about six months of diagnosis and then be followed for up to 60 months. Researchers will track outcomes including all-cause death, cardiovascular death, and hospitalizations due to heart failure. The study involves regular clinical follow-up and data collection to analyze the relationship between valve leakage measures and patient prognosis under typical care conditions.

Researchers are evaluating how often small intestinal bacterial overgrowth (SIBO) happens after people with gastroesophageal reflux disease (GERD) take proton pump inhibitors (PPIs). The study focuses on patients who have symptoms like heartburn and regurgitation and aims to better understand the relationship between PPI use and SIBO occurrence. This is an interventional study conducted by the Mayo Clinic. Participants with GERD symptoms who have been treated with a short course of PPIs will undergo breath testing to check for SIBO. During the breath test, participants drink a small carbohydrate solution and provide breath samples every 15 minutes for one hour, then every 30 minutes for the next two hours. This testing occurs approximately 8 weeks after PPI therapy to measure SIBO incidence and symptoms. Throughout the study, researchers will assess the presence of SIBO and related symptoms both before and after PPI treatment. Breath testing schedules and symptom evaluations will help determine changes associated with PPI use. The main outcome is the rate of SIBO after PPI therapy, with additional measures of symptoms and SIBO status at baseline. The study does not specify a maximum age and will enroll adults 18 years and older. Participants will be monitored until about 8 weeks after treatment.

Researchers are collecting clinical data on adults with symptomatic mitral valve disease, including those with mitral regurgitation, mitral stenosis, or mixed mitral valve disease. This observational registry aims to better understand the effects of correcting mitral valve disease on health outcomes, especially for patients who might be candidates for Transcatheter Mitral Valve Replacement (TMVR). The gathered information may also help guide future regulatory decisions for the Cephea Mitral Valve System. Participants include symptomatic patients considered suitable for TMVR by their heart care team, favoring this approach over conventional surgery or other therapies. The study will follow patients from enrollment for up to two years to observe their clinical progress. There are no specific treatments or interventions assigned by the study since it is observational. During the study, participants' health data will be collected regularly to monitor their condition and outcomes related to mitral valve disease correction. Follow-up includes reviewing clinical status and treatment effects over the two-year period. Participants must consent to data collection and follow-up visits, allowing researchers to evaluate the impact of TMVR candidacy on their health over time.

Mitral regurgitation (MR) is a common heart valve disease that can lead to heart failure. This research evaluates adult patients undergoing transcatheter mitral valve edge-to-edge repair (TEER) during hospitalization to study the occurrence of afterload mismatch (AM), a condition that limits the benefits of TEER by causing persistent heart damage and increasing mortality. The study aims to identify risk factors for AM and develop a clinical model to guide better management after TEER. The study observes adult patients receiving TEER as part of their hospital care. It follows these patients to see if they develop AM after the procedure. This observational study collects data during hospitalization and continues monitoring through an average of five years to assess long-term outcomes related to AM following TEER. Participants will be monitored for the development of afterload mismatch over the course of the study, which lasts about five years on average. Researchers will evaluate clinical factors to predict AM and use this information to build a model for guiding postoperative care. Outcome measures focus mainly on the occurrence of AM, and data collection will continue through the study completion to track patient prognosis and improve clinical decision-making.

This research aims to develop and validate an automated imaging and modeling system to analyze mitral valve prolapse (MVP) using real-time three-dimensional transesophageal echocardiography (RT3DE). The study focuses on automatically segmenting the mitral valve substructures, extracting key anatomical landmarks, and creating 3D models to assess the shape and function of degenerative MVP. Advanced deep learning and geometric tools will be used to improve analysis. Additionally, patient-specific biomechanical models will be built to study the effects of MVP and surgical repairs on the valve's structure and forces. Imaging will be performed during surgery using a specialized ultrasound system in standard views of the mitral valve and left ventricle. Surgical repair techniques include leaflet tissue removal, artificial chordae implantation, and annuloplasty for valve stabilization. When significant valve tissue is removed, samples will be collected and preserved for detailed tissue analysis. The study also involves training a neural network on segmented images to enable automated processing and 3D model generation. Participants will undergo intraoperative imaging as part of their MVP surgery, with clinical data collected anonymously. The automated system will be tested for its accuracy in segmenting valve structures and extracting features over 36 months. Biomechanical simulations will evaluate changes after surgery. No extra follow-up is needed beyond standard care. The study focuses on image analysis and modeling performed after surgery, lasting up to the completion date in 2028.

Researchers are evaluating the safety and performance of the AltaValve System to treat moderate-to-severe or severe mitral regurgitation (MR) in patients who are not suitable for surgery or other transcatheter repair options. This clinical trial focuses on adults with symptoms classified in New York Heart Association (NYHA) class II-IV, aiming to address mitral valve incompetence in targeted patient groups, including those with and without moderate to severe mitral annular calcification (MAC). The trial uses the AltaValve System, a transcatheter device designed for mitral valve replacement. Participants receive treatment through one of two groups: those without moderate mitral annular calcification and those with moderate to severe MAC. The study is non-randomized and open-label, with the device implanted to assess its safety and effectiveness in these specific populations. Participants will be monitored for at least 12 months, with key outcomes including all-cause mortality and heart failure hospitalizations. Additional assessments involve stroke, kidney injury, bleeding events, mitral valve re-intervention, technical success on the day of the procedure, changes in heart failure symptoms, walking ability, and pacemaker rates. Follow-up visits occur at various intervals up to five years, ensuring comprehensive evaluation of safety and performance over time.

Researchers are evaluating the HighLife 28mm Trans-Septal Transcatheter Mitral Valve Replacement (TSMVR) system in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgery. This early feasibility study focuses on assessing the device's feasibility, safety, and performance, especially in patients with symptomatic mitral valve abnormalities who cannot undergo conventional surgery. The study is open-label, prospective, and conducted across multiple centers in the United States. The study uses the HighLife TSMVR system, which includes a 28 mm self-expanding mitral bioprosthesis with bovine pericardium leaflets and a sub-annular implant to stabilize the valve position. The device is delivered through a minimally invasive trans-septal approach. Patients receive this single-arm investigational treatment, designed as an alternative when medical therapy is maximized, and surgery is high-risk or unsuitable. The study evaluates the device mainly at 30 days post-procedure, with longer-term safety and performance also monitored. Participants will undergo assessments including imaging tests like CT and transesophageal echocardiography to confirm valve sizing and anatomy before treatment. After the procedure, researchers will monitor for major adverse events and the device's ongoing performance. The primary outcomes focus on safety and function at 30 days, while technical success is assessed immediately after implantation. The study's total duration extends through long-term follow-up to observe sustained outcomes and safety, with careful monitoring throughout the process.

Researchers are evaluating the effectiveness of surgical treatment for less severe functional tricuspid regurgitation (TR) in patients undergoing mitral valve surgery. The study focuses on patients with mild to moderate TR (grade 2 or less) and a dilated tricuspid annulus, where current guidelines recommend surgery but lack strong scientific evidence. This multicenter, randomized trial aims to clarify whether adding tricuspid annuloplasty to mitral valve repair improves outcomes, especially in patients with degenerative disease causes. Participants will be randomly assigned to one of two groups: one receiving mitral valve repair alone (Mitral-Only Group) and the other receiving both mitral valve repair and tricuspid annuloplasty using an Edwards MC3 Tricuspid ring (M & T Repair Group). The surgical procedures occur during the same operation, with patients blinded to their group assignment. Each group will include 71 patients. During the study, researchers will monitor patients for recurrence or worsening of tricuspid regurgitation by at least two grades using transthoracic echocardiography at discharge and 12 months after surgery. They will also assess long-term outcomes at 5 and 10 years. Safety, freedom from reoperation, and progression of TR will be evaluated using statistical methods. Participants will be followed for up to 10 years after surgery.