Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System

Inclusion Criteria:

1. Moderate to severe functional tricuspid regurgitation (TR) defined as: TR severity 2+
to 4+ (according to semi-quantitative echocardiographic color flow doppler
evaluation); and Annular diameter ≥ 40 mm confirmed by echocardiography

2. Major of age( ≥ 18 years old or older per local regulation)

3. Subject has read and signed the informed consent prior to study related procedures.

4. Willing and able to comply with all required follow-up evaluations and assessments.

5. The 'Heart Team' assessment recommends TriCinch Coil Implantation

6. New York Heart Associate Classification ≥ II.

7. Left Ventricular Ejection Fraction ≥ 30%.

8. Heart failure symptoms (such as fluid retention and severe oedema, liver stasis)
despite on optimized medical therapy by the local heart team; at minimum subject on
diuretic use

9. Subject has suitable anatomy for investigational device implantation as per imaging
requirements

Exclusion Criteria:

1. Currently participating in another investigational drug or device study.

2. Subject with Systolic pulmonary arterial pressure (sPAP) > 60mmHg as measured by
Transthoracic Echocardiography (TTE)

3. Subject requiring another cardiac procedure in the framework of the index procedure;
subject requiring a percutaneous procedure within 30 days before or after the
procedure or a cardiac surgical procedure within 3 months before or after the
procedure

4. Moderate or Severe tricuspid valve stenosis (defined as a mean gradient ≥5 mmHg at
normal heart rate)

5. Aortic and/or pulmonic valve stenosis and/or regurgitation more than or equal to
moderate

6. Mitral stenosis and/or regurgitation more than moderate

7. Intra-cardiac thrombus, mass or vegetation requiring active treatment.

8. Implanted inferior vena cava (IVC) filter.

9. Prior tricuspid repair or tricuspid replacement

10. Known allergy to contrast media, silicone, PET, Co-Cr, stainless steel or nitinol that
cannot be adequately pre-medicated

11. History of cardiac transplantation

12. Contraindication to Transthoracic/Transoesophageal Echocardiography (TTE/TOE).

13. Endocarditis or severe infection within 12 months of scheduled implant procedure

14. Myocardial Infarction (MI) or known unstable angina within the 30 days prior to the
index procedure

15. Cerebro Vascular Accident within the previous 6 months

16. Hemodynamic instability or on IV inotropes

17. Contraindication to anticoagulant therapy and antiplatelet therapy

18. Documented history of bleeding diathesis, hypercoagulable or active peptic ulcer or
gastrointestinal bleeding within 3 months of scheduled implant procedure

19. Severe renal impairment or on dialysis

20. Life expectancy less than 12 months.

21. Acute anemia

22. Chronic Oral Steroid Use ≥ 6 months

23. Pregnant or lactating female of childbearing potential with a positive pregnancy test
24 hours before any study-related radiation exposure

24. Pulmonary embolism within the last 6 months

25. Tricuspid Valve Tethering distance > 10 mm

26. Presence of trans-tricuspid pacemaker or defibrillator leads which are determined as
immobile or interfering with the procedure, as evaluated by echocardiography.

27. Contra-indicated for blood transfusion or refuses transfusion

28. Patient undergoing emergency treatment

29. Patient without appropriate venous access