This study aims to investigate the efficacy and safety of combined mitral and tricuspid transcatheter edge-to-edge repair (TEER) versus isolated mitral TEER in the treatment of patients with mitral regurgitation (MR) combined with tricuspid regurgitation (TR). The expected objective is to provide a more precise treatment strategy for patients with MR combined with TR, reduce surgical risks, improve survival rates and quality of life, and offer evidence for clinical practice. The main research content involves enrolling 404 patients with severe MR combined with TR, who will be randomly assigned to either the group receiving simultaneous mitral and tricuspid TEER or the group receiving isolated mitral TEER. The primary endpoint is the composite endpoint at one year postoperatively, including death during the one-year follow-up, mitral and/or tricuspid surgery or intervention due to mitral and/or tricuspid dysfunction, rehospitalization for heart failure, and an increase of \<15 points in the KCCQ score.
Age ≥ 18 years
Moderate-to-severe or severe (≥3+) degenerative mitral regurgitation (DMR) or functional mitral regurgitation (FMR) combined with severe (≥3+) functional tricuspid regurgitation (FTR)
New York Heart Association (NYHA) functional class II, III, or IVa
Anatomically suitable for transcatheter edge-to-edge repair, as assessed by the Heart Team
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or other structural heart disease causing heart failure (except dilated cardiomyopathy of ischemic or non-ischemic etiology)
Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis)
Refractory heart failure requiring advanced therapies (e.g., left ventricular assist device or heart transplantation)
Left ventricular end-systolic diameter (LVESD) > 70 mm
Parallel
Transcatheter Edge-to-Edge Repair (TEER) System
DeviceParticipants assigned to this arm will undergo simultaneous transcatheter edge-to-edge repair (TEER) for mitral and/or tricuspid regurgitation. All participants will receive guideline-directed medical therapy (GDMT) for heart failure and valvular heart disease throughout the study period.
Composite endpoint at 12 months
Including all-cause mortality, mitral and/or tricuspid valve surgery or intervention due to mitral and/or tricuspid valve dysfunction, heart failure rehospitalization, and a KCCQ score improvement of less than 15 points.
All-cause mortality
all-cause mortality
Cardiovascular mortality
Cardiovascular mortality
Incidence of surgical procedures due to mitral and/or tricuspid valve dysfunction
Incidence of surgical procedures due to mitral and/or tricuspid valve dysfunction
Incidence of interventional procedures due to mitral and/or tricuspid valve dysfunction
Incidence of interventional procedures due to mitral and/or tricuspid valve dysfunction
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