About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Transcatheter Edge-to-Edge Repair (TEER) System