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

NCT07349888 | Not Yet Recruiting

• 1 other identifier: KY20251223-08
• Study Type: interventional
• Target: 404
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Mitral Regurgitation; Tricuspid Regurgitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• All-cause mortality

  Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

• 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

  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

  Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

• Incidence of heart failure rehospitalization

  Perioperative, 30 days, 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years

Study Arms (2)

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)

Device: Transcatheter Edge-to-Edge Repair (TEER) System

Mitral TEER

ACTIVE COMPARATOR

Participants undergo isolated mitral transcatheter edge-to-edge repair for mitral regurgitation, accompanied by GDMT

Device: Transcatheter Edge-to-Edge Repair (TEER) System

Interventions

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.

Combined Mitral and Tricuspid TEER; Mitral TEER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Symptomatic moderate-to-severe or severe degenerative mitral regurgitation (MR ≥3+)
• 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
• Severe functional tricuspid regurgitation (TR ≥3+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Conditions

Mitral Valve Insufficiency; Tricuspid Valve Insufficiency

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 28, 2031
• Study Completion (Estimated): August 31, 2031
• Last Updated: January 20, 2026

Record last verified: 2026-01