Mitral Valve Prolapse

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.

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.

Mitral valve prolapse (MVP) affects up to 3% of people and some with MVP are at risk for dangerous heart rhythm problems called ventricular arrhythmias. This subgroup, called arrhythmic MVP (AMVP), is identified by having MVP, frequent or complex ventricular arrhythmias, and no other heart rhythm causes. Researchers are studying how long-term heart rhythm monitoring can better detect these arrhythmias compared to standard 24-hour tests, aiming to improve diagnosis and plan future studies. Participants will wear a Byteflies patch ambulatory rhythm monitor for 14 days to record their heart rhythms continuously. This device will collect detailed data on premature ventricular contractions (PVCs) and more serious arrhythmias like non-sustained ventricular tachycardia, ventricular tachycardia, or ventricular fibrillation. The study focuses on the variability of these arrhythmias day-to-day and how well long-term monitoring detects arrhythmic MVP. During the study, participants will be monitored using this device for 14 days. Researchers will measure the time to detect arrhythmic MVP, count days with high PVC levels or complex arrhythmias, and assess daily changes in PVC burden. They will also explore links between arrhythmia levels and heart imaging results from MRI and echocardiography. The study starts in May 2024 and continues until June 2026, with no additional treatments involved.

Researchers are studying clinical outcomes in patients undergoing transcatheter mitral valve replacement (TMVR) for mitral insufficiency. This multinational registry focuses on patients treated with TMVR in real-world practice and collects data on those who have undergone screening for TMVR. Some historical data include patients who received other treatments like edge-to-edge repair, mitral valve surgery, or medical therapy. The registry includes patients who successfully underwent TMVR with any device. Patients who failed TMVR screening and underwent other treatments such as mitral valve edge-to-edge repair, mitral valve surgery, or medical therapy were previously included but are no longer systematically enrolled. The study collects data over various timepoints to observe the effects of these therapies. Participants are followed for at least 30 days after treatment with echocardiography and clinical evaluations. Researchers measure mitral insufficiency severity, device-related complications within 30 days, and longer-term outcomes like mortality, rehospitalization for heart failure, and unplanned mitral valve interventions over 12 months. This observational registry aims to understand outcomes and safety in patients treated with TMVR and related therapies in routine care.

Researchers are investigating the progression of moderate or greater cardiac valve stenosis and regurgitation using clinical, biological, echocardiographic, CT, and MRI data. The study aims to better understand disease progression, outcomes, and the effects of device interventions, medications, and lifestyle changes. It addresses the current lack of consensus on managing moderate valvular heart disease and the need for improved early warning mechanisms. This observational cohort study involves patients diagnosed with heart valve disease at major medical centers in China. Participants will be followed annually with outpatient visits including electrocardiography, echocardiography, blood tests, and contrast-enhanced CT scans. The study collects standardized data to identify factors that influence disease progression and adverse outcomes, guiding future treatment research. Participants will be monitored over several years with yearly assessments to track mortality, heart valve surgery, stroke, rehospitalization, valve disease progression, cardiac function, quality of life, and new cardiovascular complications. The study uses comprehensive imaging and clinical data to provide a scientific basis for improving clinical decision-making and patient care in valvular heart disease.

Researchers are evaluating the early feasibility, safety, and effectiveness of surgically implanting a polymer prosthetic heart valve in patients who need either mitral or aortic valve replacement. This exploratory study will include 10 patients, with 5 receiving the valve in the mitral position and 5 in the aortic position. The main focus is to measure valve-related complications such as thromboembolism, valve thrombosis, severe leaks, severe bleeding, and infections within 12 months after surgery. Participants will undergo surgical implantation of the polymer prosthetic valve in either the mitral or aortic position according to their group. Follow-up visits are scheduled at 30 days, between 3 to 6 months, and at 12 months after the operation to assess clinical outcomes. These assessments include echocardiographic evaluations and monitoring for clinical events related to the valve and heart function. During the study, participants will have multiple assessments including heart function classification, valve performance measurements like blood flow gradients and leakage severity, and quality of life questionnaires. Safety monitoring will cover all-cause mortality, reoperations, and valve function over the 12-month period. The study aims to provide data on initial device success and comprehensive safety outcomes, with total participation lasting at least one year following valve implantation.

Researchers are evaluating the effect and safety of adding flecainide to standard beta-blocker therapy to reduce ventricular arrhythmias in patients with arrhythmic mitral valve prolapse, a condition where the mitral valve bulges into the left atrium and can cause dangerous heart rhythms. This phase 3 randomized controlled crossover trial addresses the lack of proven treatments for patients who often experience sudden cardiac death or severe symptoms despite current therapies. The study is sponsored by Oslo University Hospital and aims to determine if combining flecainide with metoprolol is better than metoprolol alone for suppressing these arrhythmias. Participants will receive two treatment regimens in a crossover design: one with flecainide added to metoprolol, and one with metoprolol alone. Flecainide is dosed starting at 50 mg twice daily, increasing to a target of 100 mg twice daily, not exceeding 300 mg daily. Metoprolol doses are adjusted based on prior use and patient needs, up to 200 mg daily, given once or twice daily depending on the formulation and preference. The first flecainide dose is given in-hospital with heart monitoring to ensure safety. Dosages are titrated during a run-in period to maximum tolerated levels. Participants will be monitored over 12 months with implantable loop recorders to track ventricular arrhythmias, alongside assessments of premature ventricular complexes, severe ventricular tachycardias, quality of life, and safety. The study uses blinded endpoint adjudication to ensure objective evaluation of arrhythmia burden. This careful monitoring includes regular ECGs and clinical assessments to evaluate how well the treatments suppress arrhythmias and affect patients' well-being over time.

Researchers are evaluating the Eko SENSORA device, which uses artificial intelligence to detect clinically significant heart murmurs. This device records heart sounds via a digital stethoscope and analyzes them with machine learning to identify abnormalities. The study focuses on patients presenting with symptoms such as chest pain, fatigue, shortness of breath, or syncope, which can indicate heart problems. The goal is to improve detection of valvular heart disease in an emergency department setting. Participants will have their heart sounds recorded using the Eko SENSORA device placed on key areas of the chest for 15 to 30 seconds until a green light signals a good recording. The sounds are uploaded via Wi-Fi to an AI system that analyzes them without patient identifiers. The device then indicates if a significant heart murmur is present and specifies the recording location. This is an interventional study where the device's performance is being assessed. During the study, participants will be monitored for an average of 90 days to measure the number of new clinically significant heart murmurs detected. Researchers will also track the number of echocardiograms ordered. The study involves patients with cardiac risk factors and symptoms suggesting possible heart dysfunction. The device’s results and related clinical decisions will be recorded to assess its usefulness in the emergency department setting.

Researchers are studying multiple and mixed valvular heart disease (MMVD), which involves combinations of narrowed or leaking heart valves. This observational study aims to find out how common MMVD is among patients evaluated for valvular heart disease and to describe their clinical and imaging features. The study also looks at management approaches and outcomes like mortality and hospitalizations, addressing a key gap in knowledge about MMVD. The study will include patients diagnosed with MMVD through echocardiography at cardiovascular imaging departments worldwide. It is a prospective, multicenter registry involving 174 centers across 35 countries. Patients will be followed for one year, with the possibility of extending follow-up to five years. Baseline evaluations and management decisions will be made by the treating physicians following current guidelines, including options like surgery, transcatheter valve intervention, or medical care. Participants will undergo clinical assessments, imaging tests, and biomarker measurements as determined by their doctors. Follow-up will occur through visits or contact with patients or physicians to collect information on vital status, hospitalizations, strokes, and additional valve procedures. The primary measure is the proportion of MMVD cases among all valvular heart disease patients. Secondary measures include cardiovascular events, mortality, hospital admissions for heart failure, and changes in echocardiographic findings over time.

Researchers are studying the mechanobiological and histological properties of mitral valve chords in living humans, focusing on differences in elasticity between patients with mitral valve prolapse and those with restrictive ischemic mitral valve. This observational study addresses a gap in existing research, which primarily involves animal tissues or non-living human samples. The goal is to better understand mitral valve regurgitation through direct examination of living human tissue. The study will include 20 patients undergoing mitral valve replacement, selected consecutively without randomization. Tissue samples will be harvested during surgery and preserved in natural conditions without freezing to maintain their properties. Two groups are compared: one with mitral valve prolapse and the other with restrictive ischemic mitral valve movement. Data collection will include patient medical history and intraoperative results. Participants will be involved during their scheduled valve replacement surgery, when tissue samples are taken and analyzed. Researchers will measure the maximum value of Young's modulus to assess elasticity and perform initial histological evaluations of the tissue. The study aims to gather detailed mechanical and structural information on mitral valve chords, contributing to improved understanding of mitral valve disease. The total participation duration aligns with the surgical and data collection process.