TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR

Inclusion Criteria

• 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.

Exclusion Criteria

• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
• Severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180 mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg).
• Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined).
• Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.
• Mitral Regurgitation moderate-severe or greater severity (≥3+).
• Pacemaker or implantable cardioverter-defibrillator (ICD) leads that would prevent appropriate placement of TVRS Clip.
• Active endocarditis or active rheumatic heart disease or leaflets degenerated from rheumatic disease.
• Myocardial Infarction (MI) or known unstable angina within prior 30 days prior to enrollment.
• Percutaneous coronary intervention within prior 30 days prior to enrollment.
• Hemodynamic instability defined as systolic pressure 2cm) of the tricuspid leaflets