This study is for participants who have tricuspid regurgitation, a condition in which your heart's tricuspid valve does not close tightly which causes blood to flow backwards in the incorrect direction. This condition increases the workload on the heart and if left untreated, it can increase the risk of worsening heart failure. In this study, a device called the PASCAL Transcatheter Valve Repair System will be used to treat the tricuspid regurgitation. The PASCAL Transcatheter Valve Repair System is an investigational device meaning it has not been approved for commercial use by the US Food and Drug Administration (FDA). In this study participants will be randomized, meaning randomly assigned like drawing straws, in a 2:1 fashion to either receive the PASCAL Transcatheter Valve Repair System (treatment group) or optimal medical therapy (OMT) (control group). OMT means your medications will be adjusted as needed to provide the most benefit possible. Participants randomized to the OMT group may be eligible to receive the device after completing 2 years of follow up. Participants not eligible for randomization may be eligible for the registry portion of the study if approved by the sponsor. The registry arm participants will not be randomized but will undergo the procedure to place the device.

Participation in this study will last about 5 years and involve up to 15 visits for those in the treatment or registry group and 11 visit for those in the control group. Study related procedures include a right heart catheterization (test to measure the pressures in the heart), echocardiograms (ultrasound test of heart), electrocardiogram or ECG (test of the heart's electrical system) blood work, questionnaires, hall walk test, and physical exam.

This is a study to evalaute the device's safety, function, and effects on heart function, and clinical outcomes of using the Edwards APTURE system (study device) in subjects with heart failure.

Major study activities include 3 right heart catheterizations (RHC) with exercise, a computed tomography (CT) scan with contrast, multiple ultrasounds of the heart, labs, and other assessments. The length of subject participation in the study is 5 years and includes 11 research visits.

The information obtained from this study will show how safe and effective this approach is in treating the symptoms of heart failure. Alternative treatment for heart failure depends on the cause, but may include diet and exercise, managing stress, medication (such as medications to treat leg swelling, high blood pressure, or abnormal heart rate), participation in another research study or continuing with current medical therapy