Transcatheter Edge-to-Edge Repair for Tricuspid Regurgitation: Design and Rationale of the TEER-CHINA Trial.

BACKGROUND

Tricuspid regurgitation (TR) is common, and severe TR independently predicts mortality and heart failure hospitalization, leading to functional impairment and poor quality of life. Optimal medical therapy (OMT), mainly using diuretic agents, provides symptomatic relief but does not correct valvular dysfunction and is often limited by the resistance of diuretic agents. Isolated tricuspid valve surgery remains high risk. Transcatheter options have therefore emerged, with transcatheter edge-to-edge repair (TEER) widely adopted.

OBJECTIVES

The Transcatheter Edge-to-Edge Repair for Tricuspid Regurgitation in China (TEER-CHINA) study is designed to evaluate the safety and efficacy of the DragonFly-T System compared with OMT in patients with severe TR.

METHODS

The TEER-CHINA trial is a prospective, multicenter, randomized controlled trial (NCT05556460) in which a total of 236 participants will be enrolled across 35 centers in China and randomized 1:1 to the device group or OMT alone. Key inclusion criteria include patients with severe or greater TR (≥3+) who remain clinically symptomatic despite OMT for at least 30 days, are at intermediate or higher surgical risk for tricuspid valve surgery by the local Heart Team, and are anatomically suitable for use of the investigational device. Participants will be followed up at 30 days, 6 months, 12 months, and annually thereafter for up to 5 years.

RESULTS

The primary endpoint is a hierarchical composite assessed at 12 months, including all-cause mortality or tricuspid valve intervention, annualized heart failure hospitalization rates, and improvement in health status measured by the Kansas City Cardiomyopathy Questionnaire.

CONCLUSIONS

The TEER-CHINA trial is designed to assess the efficacy and safety of the DragonFly-T System and to inform future treatment strategies for severe TR.