Evaluation of Treatment With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater Tricuspid Regurgitation (TRILUMINATE)

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. Whereas, in United States patients will be followed-up till 5 years.

Inclusion Criteria:

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

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

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

4. 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.

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

1. Subjects with moderate TR: Only NYHA Class III or IV maybe considered for
inclusion.

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

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

7. The Site Heart Team concur the benefit-risk analysis supports intervention of Valvular
heart disease and that the subject is at high risk for tricuspid valve surgery.

8. 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:

9. Subjects with 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). Subjects with
moderate TR will only be included in the trial if moderate TR is accompanied by a
tricuspid annular diameter of ≥ 40mm as measured by the site heart team
echocardiographer. Note: Additional NYHA criteria for moderate TR patients(see
Inclusion Criteria #5). Additional note: If any cardiac procedure(s) that may occur
within 90-days of procedure, then TTE and TEE must be repeated prior to the index
procedure.

10. Subjects with tricuspid valve anatomy determined to be suitable for implantation
determined by the site heart team

11. Subjects with tricuspid valve anatomy evaluable by TTE and TEE

Exclusion Criteria:

1. Subject is currently participating in another clinical trial that has not yet
completed its primary endpoint.

2. 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.

3. Subjects with severe uncontrolled hypertension (Systolic blood pressure [SBP] ≥ 180
mmHg and/or Diastolic blood pressure [DBP] ≥ 110 mm Hg)

4. Subjects with Systolic Pulmonary Artery Pressure > 60 mmHg (echo determined)

5. Subjects with prior tricuspid valve leaflet surgery or any currently implanted
prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure.

6. Subjects with Mitral Regurgitation moderate-severe or greater severity (≥3+)

7. Subjects with Pacemaker or ICD leads that would prevent appropriate placement of TVRS
Clip

8. Subjects with active endocarditis or active rheumatic heart disease or leaflets
degenerated from rheumatic disease.

9. Subjects with MI or known unstable angina within prior 30 days prior to enrollment

10. Subjects with percutaneous coronary intervention within prior 30 days prior to
enrollment

11. Subjects with 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.

12. Subjects with Cerebrovascular Accident (CVA) within prior 3 months to enrollment

13. Subjects with chronic dialysis

14. Subjects with bleeding disorders or hypercoagulable state

15. Subjects with active peptic ulcer or active gastrointestinal (GI) bleeding

16. Subjects with contraindication, allergy or hypersensitivity to dual antiplatelet and
anticoagulant therapy.

17. Active infections requiring current antibiotic therapy (if temporary illness, patients
may enroll 4 weeks after discontinuation of antibiotics with no active infection).

18. Known allergy or hypersensitivity to device materials

19. 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

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

21. Subjects with life expectancy of less than 12 months due to non-cardiac conditions

Echocardiographic Exclusion Criteria:

22. Subjects with tricuspid stenosis

23. Left Ventricular Ejection Fraction (LVEF)≤20%

24. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip
positioning on the leaflets or sufficient reduction in TR. This may include:

1. Evidence of calcification in the grasping area

2. Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets