Mitral Valve Regurgitation

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 patients with symptomatic mitral valve disease, including mitral regurgitation, mitral stenosis, and mixed mitral valve disease. This observational registry aims to improve understanding of the effects of correcting symptomatic mitral valve disease on patient outcomes, particularly in those who may be candidates for Transcatheter Mitral Valve Replacement TMVR. The data may also support future regulatory or reimbursement decisions related to the Cephea Mitral Valve System. Participants include patients with symptomatic mitral valve disease who could be considered for transcatheter mitral valve replacement, based on evaluation by a specialized heart team. The study records information without assigning treatments, focusing on those judged more suitable for TMVR than conventional surgery or other therapies like transcatheter edge-to-edge repair TEER. There are no specific interventions administered as this is an observational registry. Participants provide informed consent and agree to follow study requirements, allowing ongoing data collection during their clinical care. The study monitors patients from enrollment through up to two years of follow-up to assess clinical outcomes related to mitral valve disease management. Data collected includes health status, treatment decisions, and other relevant clinical information to better understand the impact of TMVR candidacy on patient 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 valves 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 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 devices 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 devices ongoing performance. The primary outcomes focus on safety and function at 30 days, while technical success is assessed immediately after implantation. The studys 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.

Researchers are observing the safety and performance of Abbott annuloplasty devices used in surgeries to repair mitral and tricuspid valve regurgitation. This study includes devices such as the SJM Rigid Saddle Ring, SJM Sguin Annuloplasty Ring, SJM Tailor Annuloplasty Ring, and SJM Tailor Annuloplasty Band. The trial aims to meet post-market clinical follow-up requirements and follows up with participants for five years after their valve repair surgery. Participants will be grouped based on their specific valve condition and the device implanted during surgery. The five groups include primary and secondary mitral disease repairs using different annuloplasty rings, as well as primary and secondary tricuspid disease repairs using the Tailor Ring or Tailor Band. Enrollment occurs before surgery, and subjects will be implanted with one of these Abbott devices as part of their standard surgical care. After implantation, participants will complete yearly follow-up visits either in clinic or by phone for up to five years. Data collected will include any adverse events, use of cardiac medications, heart failure symptom severity measured by the New York Heart Association functional classification, and echocardiographic assessments of valve regurgitation. The study will measure outcomes such as survival rates, need for reoperation or reintervention, and improvement in heart function over time.

This research aims to study patients with primary mitral regurgitation MR to understand how diastolic dysfunction, or decreased left ventricular compliance, relates to symptom burden and exercise capacity. Current guidelines recommend surgery based on MR severity and symptoms, but symptoms do not always correlate with severity. This study explores this disconnect, especially noting differences in females and older patients with certain heart characteristics. Participants with MR preparing for mitral valve surgery or percutaneous intervention will undergo several tests. These include cardiovascular magnetic resonance imaging CMR to measure heart size, function, and scarring cardiopulmonary exercise testing CPET to assess exercise capacity and the Kansas City Cardiomyopathy Questionnaire KCCQ to evaluate quality of life and symptom burden. During left heart catheterization LHC, a specialized catheter will measure pressure and volume changes to assess left ventricular stiffness and diastolic dysfunction. Participants will be observed from enrollment through testing over eight weeks. Researchers will collect data on symptoms, exercise capacity, MR severity, and diastolic function. The study involves detailed heart imaging, exercise testing, questionnaires, and invasive pressure-volume measurements during LHC. These assessments will help clarify the relationship between symptoms, heart function, and MR severity, improving understanding of the condition.