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(for at least one location)
Describes the nature of a clinical study. Types include:
The purpose of this study is to determine if 3D volumetric measurements will allow more robust quantification of valvular heart disease severity.
Study statuses change often. Please contact us for help.
Open for enrollment
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
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 of this study is to describe hemodynamics and clinical outcomes in patients with right ventricular volume overload (RVVO).
Contact us for the latest status
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 determine if the elevated stiffness of the liver returns to normal after the surgeon performs a repair or replacement of the tricuspid valve.
The purpose of this early feasibility study is to assess the safety and performance of the Edwards Cardioband™ Tricuspid Valve Reconstruction System.
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