Clinical Trial TitleClinical TRIal to EvaLUate Cardiovascular OutcoMes IN PAtients Treated with the Tricuspid ValvE Repair System Pivotal (TRILUMINATE Pivotal)
National Clinical Trial Number:NCT03227757
Clinical Trial Protocol Description:
The purpose of this study is to evaluate the safety and effectiveness of the TriClipTM device in improving clinical outcomes in symptomatic patients with severe Tricuspid Regurgitation (TR) which included decreases incidence of heart failure symptoms, thereby reducing the number of hospitalizations for heart failure and reducing the possibility of death. The Study consists of two arms: Single Arm and Randomized Arm. Subjects will be selected to Single Arm (non-randomized, receiving device) based on an independent eligibility committee. All other eligible subjects will be randomly assigned (1:1) to treatment with either the TriClipTM device (device group) or no TriClipTM device (control group) for Randomized Arm.
Clinical Trial Eligibility Criteria:
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 any prior tricuspid valve procedure that would interfere with placement of the TriClipTM 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.