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

Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation: A Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mitral Regurgitation; Tricuspid Regurgitation
• Intervention / Treatment: Device: Transcatheter Edge-to-Edge Repair (TEER) System

• Study Type: Interventional
• Enrollment (Estimated): 404
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria General Inclusion Criteria

• 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
• Willing and able to comply with the protocol requirements and data collection procedures
• Capable of understanding the purpose of the trial and voluntarily providing written informed consent, either personally or via a legally authorized representative DMR Inclusion Criteria
• Symptomatic moderate-to-severe or severe degenerative mitral regurgitation (MR ≥3+)
• High surgical risk FMR Inclusion Criteria
• Symptomatic moderate-to-severe or severe functional mitral regurgitation (MR ≥3+)

For ventricular FMR:

• Left ventricular ejection fraction (LVEF) < 50%
• Persistent symptoms despite optimized guideline-directed medical therapy (GDMT) and cardiac resynchronization therapy (CRT), if indicated
• Clinically stable for at least 30 days prior to enrollment

For atrial FMR:

• Unsuitable for surgery
• Persistent symptoms despite optimized medical therapy
• Clinically stable for at least 30 days prior to enrollment TR Inclusion Criteria
• Severe functional tricuspid regurgitation (TR ≥3+)
• Persistent symptoms despite guideline-directed medical therapy (GDMT)
• Clinically stable for at least 30 days prior to enrollment

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combined Mitral and Tricuspid TEER; Participants undergo simultaneous transcatheter edge-to-edge repair for mitral regurgitation and tricuspid regurgitation, accompanied by guideline-directed medical therapy (GDMT)	Device: Transcatheter Edge-to-Edge Repair (TEER) System; 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.
Active Comparator: Mitral TEER; Participants undergo isolated mitral transcatheter edge-to-edge repair for mitral regurgitation, accompanied by GDMT	Device: Transcatheter Edge-to-Edge Repair (TEER) System; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): August 31, 2031

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 20, 2026

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency; Therapeutics; Drug Therapy; Drug Delivery Systems
• Other Study ID Numbers: KY20251223-08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No