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

Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement

Comparison of number of wins with composite endpoint event improvement between experimental and active comparator arm.KCCQ overall summary score is a patient-reported measure of health status, ranging from 0 to 100, where higher scores reflect better health status.NYHA functional classification system categorizes heart failure patients into 4 classes based on physical activity limitation and symptom severity: class I (no symptoms and no limitation in ordinary physical activity), class II (mild symptoms and slight limitation during ordinary activity), class III (marked limitation in activity due to symptoms, even during less-than-ordinary activity; comfortable only at rest, and class IV (severe limitations; experiences symptoms even while at rest).

Tricuspid Regurgitation (TR) severity

Comparison of percentage of patients with tricuspid regurgitation of 2+ or less between experimental and active comparator arm.TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.

Rate of Major Adverse Events (MAE)

Rate of Major Adverse Events (MAE) in experimental arm（TruGamma System in conjunction with OMT）

Procedural success rate

Procedural success rate in experimental arm.Criteria for procedural success (all of the following items shall be satisfied): No intraprocedural death or stroke;The device is successfully delivered via the jugular vein into the right atrium, across the tricuspid valve and into the right ventricle, followed by deployment of the prosthetic valve and removal of the delivery system;The implanted valve is positioned at an appropriate anatomical site;No moderate or greater transvalvular regurgitation, no moderate or greater paravalvular leakage, and no tricuspid stenosis of the implanted valve;No device-related forward flow obstruction or pulmonary embolism; No device- or access site-related complications requiring urgent reoperation or other reintervention within 24 hours after the procedure.

Clinical success rate

Clinical success rate in experimental arm.Criteria for clinical success (all of the following shall be met): No procedural death or stroke; The implanted valve is positioned at an appropriate anatomical site, with no moderate or greater transvalvular regurgitation, no moderate or greater paravalvular leakage and no tricuspid stenosis. There are no device- or access site-related complications requiring reoperation or other reintervention; No major adverse events (MAE) related to the device or procedure.

System performance evaluation

Intraoperative performance evaluation of the transcatheter tricuspid valve system, including overall device performance, ease of use of the delivery system, compatibility of the delivery system with the loaded prosthetic valve, priming performance, visualization, pushability and trackability of the delivery system, compatibility among all components of the delivery system, hemostatic performance of the delivery system, positioning function for the prosthetic valve, leaflet capture and control function, interaction between the system and adjacent anatomical structures, stability and operability during valve deployment, and retraction performance. Thrombosis or embolism shall also be assessed.The evaluation is graded into four levels: Excellent, Good, Fair, Poor.

Tricuspid Regurgitation (TR) grade reduction

Comparison of number of participants with reduction in TR between between experimental and active comparator arm.TR severity will be assessed using the 5-grade scale with the addition of "none/trace" to represent the lack of TR (scale: none/trace, mild, moderate, severe, massive, torrential). Lower grades of TR are better.