TRILUMINATE Study: Treatment of Tricuspid Regurgitation

The purpose of the study is to assess the efficacy and safety of the investigational device (TriClip^TM device) in improving clinical outcomes in patients with symptomatic severe tricuspid regurgitation. Improvement in clinical outcome is determined by reducing the severity and frequency of symptoms of heart failure, thereby decreasing the number of heart failure hospitalizations and decreasing the chance of death.

In order to participate you must meet the following criteria:

• Have severe symptomatic tricuspid regurgitation (TR).
• Are on optimal medical therapy for TR and medical and/or device therapy for mitral regurgitation, atrial fibrillation, coronary artery disease and heart failure.
• Are on New York Heart Association (NYHA) Functional Class II, III or ambulatory IV

You will be excluded from the study if any of the following criteria apply to you:

• Have systolic pulmonary artery pressure (sPAP) > 70 mmHg.
• Have severe uncontrolled hypertension systolic blood pressure (SBP) ≥ 180 mmHg and/or diastolic blood pressure (DBP) ≥ 110 mm Hg).
• Have had any prior tricuspid valve procedure that would interfere with placement of the TriClip^TM device.

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.