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Showing 1-20 of 87 trials
NCT07197736
Heart disease is the leading cause of death in the United States, and echocardiography (or "echo") is the most common way doctors look at the heart. Echo is safe, painless, and can detect major heart problems, including weak heart pumping and valve disease. Valve disease, especially aortic stenosis (narrowing) and mitral regurgitation (leakage), is common in older adults but often goes undiagnosed. While echo is the main tool for finding valve problems, it takes time, requires expert training, and results can vary between readers. Recent advances in artificial intelligence (AI), especially deep learning (DL), have shown promise in automatically analyzing heart images. However, past research hasn't fully tackled key echo techniques-like color Doppler and spectral Doppler-that are crucial for measuring how blood moves through heart valves. AI tools also face challenges in being used in everyday medical practice because of workflow issues, lack of real-world testing, and concerns about how the algorithms make decisions. At Columbia University Irving Medical Center, researchers have built a large database of heart tests over the last six years and developed AI programs to analyze echocardiograms. The current study will test whether providing AI analysis to cardiologists in real time during echo reading can make the process faster and more consistent.
NCT05061004
The objective of this study is to evaluate the preliminary safety and effectiveness of the Cephea Mitral Valve System for the treatment of symptomatic patients with mitral valve disease (including mitral regurgitation, mitral stenosis and mixed mitral valve disease) in whom transcatheter therapy is deemed more appropriate than open heart surgery.
NCT03433274
Prospective, controlled, multicenter clinical investigation with four trial cohorts: Randomized, Non-repairable, Severe Mitral Annular Calcification (MAC) and Severe Mitral Annular Calcification Continued Access Plan (MAC CAP). Subjects in the Randomized cohort were randomized in a 1:1 ratio to the trial device or to the MitraClip system. Subjects in the Non-repairable, Severe MAC, and Severe MAC CAP cohorts were receive the trial device. The objective of the Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation (SUMMIT) was to evaluate the safety and effectiveness of the Tendyne Transcatheter 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. This randomized controlled trial would provide the opportunity to evaluate the safety and clinical benefits of the Tendyne Transcatheter Mitral Valve System compared to the MitraClip System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation, within approved MitraClip indications. In addition, the safety and effectiveness of the Tendyne Transcatheter Mitral Valve System would be evaluated in patients with severe mitral annular calcification who are at prohibitive risk for mitral valve surgery. Patients who were not suitable for mitral valve surgery for reasons other than severe mitral annular calcification and were also not suitable for transcatheter repair with MitraClip, would be enrolled in the Non-repairable cohort. Subjects would be seen at screening, pre- and post-procedure, discharge, 30 days, 3 months, 6 months, and annually through 5 years.
NCT06099665
This multi-center, prospective, cluster-randomized controlled trial will evaluate Tempus Next automated notifications as an intervention to support identification and evaluation of patients possibly indicated for Valve Intervention (VI). This study will evaluate the impact of Tempus Next's automated notifications on: (1) Transcatheter or surgical procedure for AS or MR; and (2) Clinic visit with at least one member of the Multidisciplinary Heart Team (including time to evaluation) for patients with definitive or possible severe AS or MR on echocardiogram. These endpoints will also be examined within and between assigned groups according to race, ethnicity, sex, and geography. The primary question that will be answered: Do automated alerts sent to clinical providers decrease under-treatment of severe aortic stenosis and severe mitral regurgitation? The study will compare the rate of clinical follow-up and aortic valve surgery in a control group (no alerts sent) to a treatment group (alerts sent to an appropriate care provider).
NCT07450911
An evaluation of the ReValve System for treatment of clinically significant mitral regurgitation in subjects determined appropriate for mitral valve surgery.
NCT04153292
This study will establish the safety and effectiveness of the SAPIEN M3 System in subjects with symptomatic, at least 3+ mitral regurgitation (MR) for whom commercially available surgical or transcatheter treatment options are deemed unsuitable. Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.
NCT07349888
This study aims to investigate the efficacy and safety of combined mitral and tricuspid transcatheter edge-to-edge repair (TEER) versus isolated mitral TEER in the treatment of patients with mitral regurgitation (MR) combined with tricuspid regurgitation (TR). The expected objective is to provide a more precise treatment strategy for patients with MR combined with TR, reduce surgical risks, improve survival rates and quality of life, and offer evidence for clinical practice. The main research content involves enrolling 404 patients with severe MR combined with TR, who will be randomly assigned to either the group receiving simultaneous mitral and tricuspid TEER or the group receiving isolated mitral TEER. The primary endpoint is the composite endpoint at one year postoperatively, including death during the one-year follow-up, mitral and/or tricuspid surgery or intervention due to mitral and/or tricuspid dysfunction, rehospitalization for heart failure, and an increase of \<15 points in the KCCQ score.
NCT06780241
This project aims to validate sex-specific biologic signatures associated with aortic valve disease developed in a large multicenter CMR registry, using unsupervised phenomapping. The aim to use standard and advanced CMR techniques (MRF, DTI, chemical exchange transfer, and radiomics analysis) is to determine advanced CMR predictors of reverse remodeling following aortic valve surgery and develop sex-specific thresholds for risk. Infrastructure developed by this study will enable development of an innovative, scalable, sex-specific precision medicine cardiovascular imaging pipeline to determine overall risk and treatment response.
NCT04147884
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
NCT07243158
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.
NCT03142152
The objective of this prospective, randomized, blinded clinical trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating heart failure with functional regurgitation (FMR).
NCT05965258
The goal of the current research is to develop personalized risk prediction for functional mitral regurgitation (FMR) patients through explainable unsupervised phenomapping enriched with advanced cardiac magnetic resonance (CMR) imaging biomarkers, and to determine the CMR predictors of reverse remodeling following modern therapies for FMR. The prospective study entails aiming to recruit 360 adult patients (ages \>18 years) with EF 10-50% and FMR RF\> 20%, who are clinically referred for CMR evaluation. Patients who enroll in our study will be referred for optimization of mGDMT and will undergo follow-up CMR studies at 6months. NICM patients who are fully medically optimized with significant FMR at the time of the baseline CMR and are referred for Mitraclip treatment will undergo follow-up CMR 6 months from Mitraclip intervention. NICM patients referred for mGDMT optimization, but have persistent or progressive FMR at the time of 6 month follow-up CMR and referred for Mitraclip therapy, will undergo a 2nd follow-up CMR 6 months from Mitraclip therapy.
NCT06282042
To explore the impact of early transcatheter edge-to-edge repair of acute functional mitral regurgitation after myocardial infarction on the combined incidence of death and heart-failure associated hospitalisations at one-year follow-up, and quality of life and LV remodelling at two-year follow-up.
NCT06255457
Study objectives: * To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline to 6 months after surgery * To characterize the molecular landscape of arrhytmogenic MVP Study design: -Prospective explorative observational study Study population: -90 patients with arrhytmogenic MVP and without arrhytmogenic MVP (controls) eligible for mitral valve surgery for mitral regurgitation will be enrolled. All patients will be evaluated with cardiac magnetic resonance (CMR) imaging and continuous seven day arrhythmic monitoring before and at 6 months after mitral valve surgery
NCT07151495
Mitral valve prolapse is the most common cause of mitral regurgitation requiring surgery in developed countries. While cardiac surgery is recommended for symptomatic patients, in accordance with the ESC guidelines on valvular heart disease, indications for intervention in asymptomatic patients are mainly based on two-dimensional echocardiographic criteria: the presence of left ventricular systolic dysfunction or dilatation (end-systolic diameter ≥ 40 mm and/or ejection fraction ≤ 60%); or, in patients with preserved left ventricular systolic function, the occurrence of atrial fibrillation secondary to valvular disease or pulmonary hypertension (systolic pulmonary artery pressure \> 50 mmHg); finally, significant left atrial dilatation (indexed left atrial volume ≥ 60 ml/m² or diameter ≥ 55 mm) also represents an indication. Mitral valve repair is preferred over valve replacement with a prosthesis, as it is associated with lower intraoperative mortality, better long-term survival, and fewer valve-related complications. However, the cut-off values derived from conventional echocardiography and used as indicators for surgical intervention may reflect an already severe and irreversible structural and functional cardiac alteration. Moreover, they do not consider more advanced imaging techniques such as speckle tracking echocardiography, which is now widely used in clinical practice and allows for a quantitative assessment of myocardial function through the analysis of myocardial fiber shortening in the cardiac walls. Several studies have shown that preoperative peak left atrial longitudinal strain (PALS) has prognostic value in predicting postoperative clinical outcomes in patients undergoing surgery for primary mitral regurgitation, as well as in predicting left atrial reverse remodeling; this prognostic relevance has also been observed in asymptomatic patients and in cases of less than severe mitral regurgitation. Furthermore, Bernard et al. demonstrated the prognostic value of a staging system for extra-valvular cardiac damage, assessed using two-dimensional echocardiographic data, in asymptomatic patients with moderate or severe mitral regurgitation.
NCT06917664
This study aims to evaluate the effect of angiotensin receptor/neprilysin inhibitors (ARNI) on improving ischemic mitral regurgitation (IMR) in patients with coronary artery disease undergoing isolated coronary artery bypass grafting (CABG) through a randomized controlled clincial trial.
NCT07085650
Atrial fibrillation (AF) is the most common cardiac arrhythmia in the clinic and can lead to valve regurgitation and a poor prognosis. At present, atrial fibrillation ablation is one of the most effective means for the recurrence of atrial fibrillation in clinical practice, but the recurrence rate is high. Therefore, it is of great significance to find the predictors of relapse after atrial fibrillation ablation for clinical precision treatment. three-dimensional transesophageal ultrasound (3D-TEE) can comprehensively evaluate the valve regurgitation, flap ring changes, atrial or auricular thrombosis in patients with atrial fibrillation. It is also a necessary examination before atrial fibrillation ablation. Therefore, this study intends to combine 3D-TEE and three-dimensional transthoracic echocardiographic (3D-TTE) examination to evaluate the cardiac structure and function of patients. To comprehensively evaluate atrial fibrillation valve regurgitation and explore the predictors of recurrence after atrial fibrillation ablation.
NCT04177394
This primary objective of the EXPAND G4 study is to confirm the safety and performance of the MitraClip G4 System in a post-market setting.
NCT07055919
This trial aims to evaluate the safety and efficacy of the Structural Heart Surgery Assist System in assisting TEER for patients with moderate-to-severe or greater degenerative or functional mitral regurgitation (MR ≥3+). A prospective, multicenter, stratified randomized controlled design with non-inferiority comparison will be used. The experimental group will utilize the Structural Heart Surgery Assist System, while the control group will undergo manual TEER (e.g., MitraClip G4).
NCT04430075
This is a postmarket clinical follow up study on the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System and the Edwards PASCAL Precision Transcatheter Valve Repair System in transcatheter mitral valve repair.