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Combined Mitral and Tricuspid Versus Isolated Mitral Transcatheter Edge-to-Edge Repair for Mitral Regurgitation With Tricuspid Regurgitation (DUAL-TEER Trial) | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

NCT07349888•Nanjing First Hospital, Nanjing Medical University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
•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
+7 more criteria

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)
+18 more criteria

Key Dates

Start Date

February 1, 2026

Primary Completion Date

February 28, 2031

Completion Date

August 31, 2031

Last Updated

January 20, 2026

Enrollment

404

ESTIMATED participants

Conditions

Mitral RegurgitationTricuspid Regurgitation

Interventions

Transcatheter Edge-to-Edge Repair (TEER) System

DEVICE

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

NCT07450911

Mitral Regurgitation

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RECRUITINGNA

A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.

NCT07433504

Severe or Greater Tricuspid Regurgitation

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RECRUITINGNA

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System

A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

Early Transcatheter Mitral Valve Repair After Myocardial Infarction

Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery

Treatment of Moderate Ischemic Mitral Regurgitation in Patients With Coronary Artery Disease