A Study to Evaluate the Safety and Performance of TruGamma System for Tricuspid Replacement

Pivotal trial to evaluate the safety and effectiveness of the TruGamma tricuspid valve replacement system

Inclusion Criteria: 1. Age ≥65 years old. 2. The subject must be assessed by the local heart team as a high-risk patient ineligible for surgery and has been stabilized on optimal medical therapy (OMT)（The OMT is evaluated by the local heart team and comprises medications including diuretics with a treatment duration of no less than 30 days; no medication was newly initiated or discontinued within the preceding 2 weeks before treatment, any dose reduction did not exceed 50% of the original dose, and any dose escalation did not exceed 100% of the original dose.）. 3. Despite OMT per the local heart team, patient has signs of TR or symptoms fromTR，and TR graded as at least severe on a TTE(assessedby the 5-grade classification). 4. New York Heart Association (NYHA) Class III-IV. 5. The local heart team determines that the subject's anatomy is appropriate for transcatheter tricuspid valve replacement. 6. Subject is willing and able to comply with all study evaluations and provideswritten informed consent. Exclusion Criteria: 1. Transesophageal echocardiography (TEE) is contraindicated or cannot be completed. 2. Pulmonary arterial systolic pressure (PASP) \>60 mmHg by Dopplerechocardiogram (unless right heart catheterization \[RHC\] demonstrates PASP ≤60 mmHg). 3. Left ventricular ejection fraction (LVEF) ≤ 25%. 4. Severe aortic, mitral, and/or pulmonic valve stenosis and/or regurgitation requiring surgical intervention. 5. Previous tricuspid surgery or intervention. 6. Patients with congenital Ebstein's anomaly or hypoplastic right ventricle. 7. Patients with right ventricular outflow tract obstruction,or hemodynamically significant pericardial effusion,or significant intracardiac mass, thrombus, or vegetation. 8. Active endocarditis within the last 90 days or infection requiring antibiotictherapy within the last 14 days. 9. Hemodynamic instability with cardiogenic shock or severe hemodynamic compromise, defined as systolic blood pressure (SBP) \