Trial to evaluate the transcatheter tricuspid valve repair with the Edwards PASCAL Transcatheter Valve Repair System and optimal medical therapy (OMT) compared to OMT alone in patients with tricuspid regurgitation

The research study is being conducted to determine the safety and effectiveness of an investigational device, the Edwards PASCAL Transcatheter Valve Repair System (hereinafter referred to as the PASCAL System), with optimal medical therapy (OMT) compared to optimal medical therapy alone in the treatment of patients with symptomatic, severe tricuspid regurgitation (TR). Participants will be asked to complete the following research procedures: routine screening assessments such as medical exams, blood work, electrocardiograms (EKG), transthoracic echocardiogram (TTE), transesophageal echocardiogram (TEE) and the completion of several health status questionnaires.Participants who are a Roll-In, CLASP II TR Registry Randomized test group, or crossover patient, will undergo a minimally invasive catheterization procedure in which their doctor will implant the PASCAL device under fluoroscopy and TEE guidance. All patients will be followed through five (5) years. Follow up visits include routine medical exams, blood work, EKG, TTE, and health status questionnaires.

You may be eligible for this study if you meet the following criteria:

• Conditions: tricuspid regurgitation, heart failure
• Age: 18 years - 99 years
• Gender: All