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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
404
Participants 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.
Time frame: 12 months
All-cause mortality
all-cause mortality
Time frame: Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Cardiovascular mortality
Cardiovascular mortality
Time frame: Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Incidence of surgical procedures due to mitral and/or tricuspid valve dysfunction
Incidence of surgical procedures due to mitral and/or tricuspid valve dysfunction
Time frame: Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Incidence of interventional procedures due to mitral and/or tricuspid valve dysfunction
Incidence of interventional procedures due to mitral and/or tricuspid valve dysfunction
Time frame: Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Incidence of heart failure rehospitalization
Incidence of heart failure rehospitalization
Time frame: Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years
Cardiac function change
Change in New York Heart Association (NYHA) Functional Classification, a clinician-assessed scale ranging from Class I to Class IV, with higher class indicating worse functional status.
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Quality of life of patients
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score, a patient-reported outcome measure ranging from 0 to 100, with higher scores indicating better health-related quality of life.
Time frame: 30 days, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years
Quality of life of patients
Changes in 6-minute walking distance
Time frame: Perioperative, 6 months, 12 months
Technical success
Successful implantation of the transcatheter edge-to-edge repair system, with immediate postoperative echocardiographic assessment showing MR and/or TR ≤2+, and no death or surgical reintervention prior to discharge.
Time frame: Perioperative
The incidence of major adverse cardiovascular and cerebrovascular events during the trial (MACCEs)
Cardiac death, stroke, myocardial infarction, renal disease requiring unplanned dialysis or renal replacement therapy, unplanned or urgent intervention (interventional or surgical procedure) due to device-related complications, severe bleeding (as defined by MVARC), and access-related vascular complications requiring intervention.
Time frame: Perioperative, 30 days, 6 months, 12 months
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