Early Feasibility of 'Pivot Extend' for Tricuspid Regurgitation Treatment

Inclusion Criteria:

1. Adults 18 years of age or older at the time of screening

2. Those with symptoms despite medical therapy (OMT, diuretics/medications) for TR forat least 1 month at screening

3. Those who meet the criteria of severe (3+) or worse on the TR grade classificationtable on echocardiography performed at the screening visit

4. Those with clinical symptoms of New York Heart Association (NYHA) class 2 or worse

5. Those deemed suitable for percutaneous valve intervention by a Heart Team thatincludes at least one cardiologist, one cardiac surgeon and one anesthesiologist.

6. Those who have voluntarily decided to participate in this clinical trial and haveprovided written informed consent

7. Those who can understand and follow the investigator's instructions and are able toparticipate for the entire duration of the study

Exclusion Criteria:

1. Those with blood clots, emboli, masses, or growths in the vascular system of theheart or lungs on an echocardiogram and cardiac CT scan performed at the screeningvisit

2. Those with uncorrected blood clotting disorders based on hemanalysis performed atthe screening visit

3. Those who are unable to use anticoagulant agents (NOAC ex.Xarelto)

4. Those who have had major bleeding (not including minor bleeding, such as a nosebleedthat can be hemostasized) treated with anticoagulants prior to participation in thisclinical trial

5. Those with severe anemia (hemoglobin ≦10g/dL) that requires hospitalization

6. Those who have an implanted device such as an implantable cardioverter defibrillator (ICD) or pacemaker prior to participation in this clinical trial

7. Those whose anatomy, in the opinion of the investigator, is not suitable forimplantation of an investigational medical device based on echocardiogram andcardiac CT scan performed at the screening visit

8. Those who require surgery or interventional procedures (coronary artery bypass graft (CABG) or surgery for atrial septal defect (ASD)) based on an echocardiogramperformed at the screening visit

9. Those with a platelet count of 80,000/uL or less based on hemanalysis performed atthe screening visit

10. Patients with pulmonary arterial hypertension with a TR Vmax greater than 3.5 m/s onechocardiography performed at the screening visit or a pulmonary vascular resistanceof more than 3 Wood Units on right heart catheterization

11. Those with a left ventricular ejection fraction (LVEF) of less than 50% onechocardiogram performed at the screening visit

12. Those who have had active gastrointestinal bleeding or a digestive procedure within 3 months prior to participation in this study (those with the potential forgastrointestinal bleeding)

13. Those with a history of cerebrovascular accident (CVA) or transient ischemic attacks (TIA) within 30 days prior to participation in this clinical trial

14. Those with a history of myocardial infarction (MI) within 30 days prior toparticipation in this study

15. Those with active endocarditis requiring antibiotic treatment

16. Those with malignancies with end-stage renal failure requiring hemodialysis andother chronic conditions who have a life expectancy of less than one year

17. Those with moderate or severe aortic, pulmonary artery, or mitral stenosis onechocardiogram performed at the screening visit

18. Those with moderate or worse mitral valve regurgitation or severe aortic valveregurgitation on the echocardiogram performed at the screening visit

19. Those with calcification of the tricuspid valve lobes affecting the procedure on anechocardiogram performed at the screening visit

20. Those who have participated in another clinical trial within 30 days prior toparticipation in this clinical trial

21. Pregnant or nursing women, or women planning to become pregnant during the clinicaltrial period

22. Women of childbearing potential who are not using a medically accepted birth controlmethod

23. Those with a coexisting condition, which most likely limits the participant´s lifeexpectancy to less than one year.

24. Those with a preexisting pulmonary valve prosthesis or RV to PA conduit.

25. Those with clinical findings other than the above that, in the opinion of theinvestigator, are medically inappropriate for this clinical trial