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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Mitral and Tricuspid TEER | Experimental | Participants undergo simultaneous transcatheter edge-to-edge repair for mitral regurgitation and tricuspid regurgitation, accompanied by guideline-directed medical therapy (GDMT) |
|
| Mitral TEER | Active Comparator | Participants undergo isolated mitral transcatheter edge-to-edge repair for mitral regurgitation, accompanied by GDMT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter Edge-to-Edge Repair (TEER) System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | all-cause mortality | Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years |
| Cardiovascular mortality | Cardiovascular mortality |
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Inclusion Criteria General Inclusion Criteria
For ventricular FMR:
For atrial FMR:
Exclusion Criteria:
Tricuspid annular plane systolic excursion (TAPSE) < 10 mm, or Right ventricular tissue Doppler imaging S' < 6 cm/s, or Fractional area change (FAC) ≤ 22%
-Hemodynamic instability, defined as: Systolic blood pressure < 90 mmHg with afterload reduction, or Cardiogenic shock requiring inotropic support, intra-aortic balloon pump, or ther mechanical circulatory support
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|
| 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 | 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 | 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 | 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. | 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. | 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 | 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. | 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. | Perioperative, 30 days, 6 months, 12 months |
| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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