Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation (DUAL-TEER Trial)

Exclusion Criteria

• •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
• •Left ventricular ejection fraction (LVEF) ≤ 20%
• •Pulmonary arterial hypertension as assessed by right heart catheterization (RHC)
• •Severe right ventricular dysfunction, defined as:
• •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
• •Severe uncontrolled hypertension (systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 110 mmHg)
• •Myocardial infarction or unstable angina within 30 days prior to enrollment
• •Significant untreated coronary artery disease requiring revascularization, or coronary intervention performed within 30 days prior to enrollment
• •Moderate or greater aortic valve or pulmonary valve stenosis or regurgitation Mitral valve anatomy deemed unfavorable for transcatheter edge-to-edge repair by the Heart Team, including:Moderate-to-severe calcification in the grasping zone; Mitral valve orifice area \< 3.5 cm²; Posterior mitral leaflet length \< 7 mm; Mitral stenosis; Leaflet perforation; Multi-segment disease or multiple chordal rupture Tricuspid valve anatomy deemed unfavorable for transcatheter edge-to-edge repair by the Heart Team, including:Moderate-to-severe calcification in the grasping zone; Coaptation gap ≥ 10 mm; Severe leaflet perforation, cleft lesions, or other conditions preventing device implantation
• •Congenital Ebstein's anomaly
• •Prior surgical or interventional procedure involving the mitral or tricuspid valve
• •Pacemaker or implantable cardioverter-defibrillator (ICD) leads interfering with proper device positioning
• •Intracardiac thrombus, vegetation, mass, or tumor in the atria or ventricles
• •Cerebrovascular accident (stroke) within 3 months prior to enrollment
• •Chronic obstructive pulmonary disease requiring continuous home oxygen therapy or long-term outpatient oral steroid treatment
• •End-stage renal disease requiring chronic dialysis
• •Vascular access limitations, including inferior vena cava filter, severely tortuous or obstructed caval system, or difficult transseptal puncture
• •Contraindications to antithrombotic therapy, or history of intracerebral hemorrhage, gastrointestinal bleeding, or bleeding disorders within 3 months prior to enrollment
• •Uncontrolled active infection, including active bacterial endocarditis
• •Severe comorbidities that may complicate treatment evaluation (e.g., coma, malignancy, or severe psychiatric disorders)
• •Pregnancy or breastfeeding
• •Life expectancy \< 1 year
• •Participation in another clinical trial that has not yet reached its primary endpoint
• •Investigator judgment that the patient is non-compliant or unlikely to complete follow-up as required