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

This is a prospective, single arm, multi-center study.

A minimum of 85 subjects will be prospectively enrolled into this single arm study in approximately 25 sites, in Europe, Canada and the United States. Patients will be seen for follow-up visits at discharge (≤ 7 days post index procedure), 30 days, 6 months, 1,2,3 years.

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 < 90 mmHg with or without afterload reduction, cardiogenic shock or the need for inotropic support or intra-aortic balloon pump or other hemodynamic support device.
• Cerebrovascular Accident (CVA) within prior 3 months to enrollment.
• Chronic dialysis.
• Bleeding disorders or hypercoagulable state.
• Active peptic ulcer or active gastrointestinal (GI) bleeding.
• Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulant therapy.
• Active infections requiring current antibiotic therapy (if temporary illness, patients may enroll 4 weeks after discontinuation of antibiotics with no active infection).
• Known allergy or hypersensitivity to device materials.
• In the judgement of the investigator, a condition that could limit a patient's ability or unwillingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
• Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombus or vegetation.
• Life expectancy of less than 12 months due to non-cardiac conditions.

Echocardiographic Exclusion Criteria:

• Tricuspid stenosis.
• Left Ventricular Ejection Fraction (LVEF) ≤20%.
• Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may include:

• Evidence of calcification in the grasping area
• Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets