TRILUMINATE Pivotal Trial

Inclusion Criteria:

• In the judgment of the site local heart team, subject has been adequately treatedper applicable standards (including medical management) and stable for at least 30days as follows:

• Optimized medical therapy for treatment of TR (e.g. diuretics).

• Medical and/or device therapy, for mitral regurgitation, atrial fibrillation,coronary artery disease and heart failure.

• The Eligibility Committee will confirm that the subject has been adequatelytreated medically.

• Subject is symptomatic with Severe TR despite being optimally treated as describedabove. TR severity is determined by the assessment of a qualifying TTE and confirmedby the ECL. The ECL will also request a TEE to confirm TR etiology. Note: If anycardiac procedure(s) occur after eligibility was determined, TR severity will needto be re-assessed 30 days after the cardiac procedure(s).

• The cardiac surgeon of the site local heart team concur that the patient is atintermediate or greater estimated risk for mortality or morbidity with tricuspidvalve surgery.

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

• In the judgment of the TriClip(TM) implanting Investigator, femoral vein access isdetermined to be feasible and can accommodate a 25 Fr catheter.

• Age ≥18 years at time of consent.

• Subject must provide written informed consent prior to any trial related procedure.

Exclusion Criteria:

• Systolic pulmonary artery pressure (sPAP) > 70 mmHg or fixed pre-capillary pulmonaryhypertension as assessed by right heart catheterization (RHC)

• Severe uncontrolled hypertension Systolic Blood Pressure (SBP) ≥ 180 mmHg and/orDiastolic Blood Pressure (DBP) ≥ 110 mm Hg

• Any prior tricuspid valve procedure that would interfere with placement of theTriClip(TM) device

• Indication for left-sided (e.g. severe aortic stenosis, severe mitral regurgitation)or pulmonary valve correction prior 60 days. Note: Patients with concomitant Mitraland tricuspid valve disease will have the option of getting their MR treated, andwait 60 days prior to being reassessed for the trial.

• Pacemaker or ICD leads that would prevent appropriate placement of the TriClip(TM)clip.

• Tricuspid valve stenosis - Defined as a tricuspid valve orifice of ≤ 1.0 cm2 and/ormean gradient ≥5 mmHg as measured by the ECL

• Left Ventricular Ejection Fraction (LVEF) ≤20%

• Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clippositioning 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

• Severe leaflet defect(s) preventing proper device placement

• Ebstein Anomaly - Identified by having a normal annulus position while thevalve leaflets are attached to the walls and septum of the right ventricle.

• Tricuspid valve anatomy not evaluable by TTE and TEE

• Active endocarditis or active rheumatic heart disease or leaflets degenerated fromrheumatic disease (i.e. noncompliant, perforated).

• MI or known unstable angina within prior 30 days

• Percutaneous coronary intervention within prior 30 days

• Hemodynamic instability defined as systolic pressure < 90 mmHg with or withoutafterload reduction, cardiogenic shock or the need for inotropic support orintra-aortic balloon pump or other hemodynamic support device.

• Cerebrovascular Accident (CVA) within prior 90 days

• Chronic dialysis

• Bleeding disorders or hypercoagulable state

• Active peptic ulcer or active gastrointestinal (GI) bleeding

• Contraindication, allergy or hypersensitivity to dual antiplatelet and anticoagulanttherapy.

• Note: Contraindication to either antiplatelet or anticoagulant therapy (individually not both therapies) is not an exclusion criterion.

• Ongoing infection requiring current antibiotic therapy (if temporary illness,patients may enroll 30 days after discontinuation of antibiotics with no activeinfection).

• Known allergy or hypersensitivity to device materials

• Evidence of intracardiac, inferior vena cava (IVC), or femoral venous mass, thrombusor vegetation.

• Life expectancy of less than 12 months

• Subject is currently participating in another clinical trial that has not yetcompleted its primary endpoint.

• Subject is currently participating in another clinical investigation for valvularheart disease(s).

• Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period. Female subjects of child-bearing potential arerequired to have a negative pregnancy test done within 7 days of the baseline visitper site standard test. Female patients of childbearing potential should beinstructed to use safe contraception (e.g., intrauterine devices, hormonalcontraceptives: contraceptive pills, implants, transdermal patches hormonal vaginaldevices, injections with prolonged release.) It is accepted, in certain cases, toinclude subjects having a sterilized regular partner or subjects using a doublebarrier contraceptive method.

• Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results.