Ensayos clínicos

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

The purpose of this study is to look at liver stiffness with a MRI sequence called Magnetic Resonance Elastography (MRE). The study will let the investigators know whether the subject's liver is normal or has increased stiffness. Increased liver stiffness often means there is chronic liver disease and fibrosis. Increased right heart pressure and congestive heart failure are considered risk factors for development of liver fibrosis. Liver fibrosis, if progressive, may lead to cirrhosis and its related complications. The increased liver stiffness may be due to a poorly functioning tricuspid valve. With this research, the investigators will be able to ...

The purpose of this early feasibility study is to assess the safety and performance of the Edwards Cardioband™ Tricuspid Valve Reconstruction System.

The purpose of this study is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in your heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

The purpose of this study is to determine the efficacy of a strategy of rhythm control to treat severe TR due to AF, followed by early surgery in non-responders to rhythm contron and to determine baseline clinical and hemodynamic predictors of symptom benefit following effective TR reduction. 

The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

The purpose is to study the correlation of right ventricular strain by tissue Doppler and Tricuspid Annular Plane Systolic Excursion (TAPSE) in patients without a tricuspid regurgitation jet with the presence and severity of pulmonary artery hypertension diagnosed by right heart catheterization. The primary aim is to determine the correlation of other echocardiographic, laboratory and clinical findings in patients without a tricuspid regurgitation jet with the presence and severity of pulmonary artery hypertension diagnosed by right heart catheterization. As such, one goal is to potentially create a predictive score with adequate sensitivity to determine which patients without a tricuspid regurgitation ...

Classical echocardiographic assessment of heart valves is critical in determination of disease severity. However, echocardiography has only limited ability to predict how well an individual patient will do at time of surgery. New echocardiographic technology allows us to measure new, more refined parameters of your heart’s performance. This study is investigating whether these new parameters are better in predicting outcomes.

This study is being done to determine whether or not new blood test(s) can determine the severity of heart conditions. Aortic stenosis, hypertrophic cardiomyopathy, mitral regurgitation, aortic regurgitation, artificial heart valve regurgitation or stenosis, and tricuspid valve regurgitation associated with pacemaker leads are the cardiac disorders under study. The blood tests involve analysis for von Willebrand Factor antigen and activity, von Willebrand Factor multimers, and brain natriuretic peptide (BNP) levels. The results of the blood tests will be compared to the information from the clinically-indicated echocardiogram and one blood test compared to another.

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.