Triluminate Pivotal Study
Condition: Tricuspid regurgitation
Key Inclusion Criteria
- Participant has been adequately treated (including medical management) and stable for at least 30 days.
- Symptomatic with severe tricuspid regurgitation despite being optimally treated
- At least 18 years old
Key Exclusion Criteria
- Systolic pulmonary artery pressure >70 mmHg or fixed pre-capillary pulmonary hypertension as assessed by right heart catheterization
- Severe uncontrolled hypertension systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mm Hg
- Any prior tricuspid valve procedure that would interfere with placement of the TriClip device
Full Study Name
Clinical Trial to Evaluate Cardiovascular Outcomes in Patients Treated With the Tricuspid Valve Repair System Pivotal (TRILUMINATE Pivotal) (IRB no. 00000142)
This study focuses on patients who have severe or greater tricuspid regurgitation (TR) and who have symptoms due to heart failure despite being treated with currently available therapies. TR occurs when the leaflets of the tricuspid valve do not close properly, causing blood to leak backward with each heartbeat. The purpose of the study is to compare the performance of an investigational tricuspid valve repair system (TriClip Device) plus optimal drug therapy with optimal drug therapy alone. The device consists of a delivery catheter and an implantable tricuspid valve repair clip (the TriClip) to repair the tricuspid valve.
Participants will be randomly assigned to one of two study groups: the device group (those who receive the TriClip device) or the No TriClip device group (control/medical therapy group).