Trial to Evaluate Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)

• Subject must be ≥18 years and ≤ 90 years at time of consent and must not be a member of a vulnerable population.

• Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure.

• Subject must agree not to participate in any other clinical trial for a period of one year following the index procedure.

• In the judgment of the investigator at the site, the subject has been adequately treated per applicable standards, including for coronary artery disease, mitral regurgitation and heart failure at least 30-days prior to index procedure. The Eligibility Committee must concur that the subject has been adequately treated.

• New York Heart Association (NYHA) Functional Class II (conditional), III, or ambulatory IV

∙ Subjects with moderate TR: Only NYHA Class III or IV may be considered

‣ Subjects with severe or greater TR: NYHA II, III, or IV may be considered for inclusion

• No indication for left-sided or pulmonary valve correction.

• The Site Heart Team concur the benefit-risk analysis supports intervention for tricuspid regurgitation per current guidelines for the management of Valvular heart disease and that the subject is at high risk for tricuspid valve surgery.

• In the judgement of the TVRS implanting investigator, femoral vein access is determined to be feasible and can accommodate a 25 Fr catheter.

• Echocardiographic Inclusion Criteria:

• Moderate or greater (≥2+) Tricuspid Regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and transesophageal echocardiogram (TEE) confirmed by the Echocardiography Core Lab (ECL).

⁃ Tricuspid valve anatomy determined to be suitable for implantation determined by the site heart team.

⁃ Tricuspid valve anatomy evaluable by TTE and TEE.