AzTrials
AzTrials

Mitral RegurgitationNCT07349888

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

A study testing Transcatheter Edge-to-Edge Repair (TEER) System in people with Mitral Regurgitation and Tricuspid Regurgitation, run by Nanjing First Hospital, Nanjing Medical University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mitral Regurgitation, Tricuspid Regurgitation
What is being tested?
Transcatheter Edge-to-Edge Repair (TEER) System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
404 participants
Where
No sites listed yet
Study dates
1 Feb 2026to 31 Aug 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 20Show fewer
  • 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

Who cannot join

  • 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)
Show all 28Show fewer
  • 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

About this study

Official title: 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.

Being tested
Transcatheter Edge-to-Edge Repair (TEER) System
Medical subject headings
Mitral Valve Insufficiency, Tricuspid Valve Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcatheter Edge-to-Edge Repair (TEER) SystemDevice

    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.

Study groups in NCT07349888
Study groupRoleWhat they receive
Combined Mitral and Tricuspid TEERExperimentalParticipants undergo simultaneous transcatheter edge-to-edge repair for mitral regurgitation and tricuspid regurgitation, accompanied by guideline-directed medical therapy (GDMT)
Receives: Device: Transcatheter Edge-to-Edge Repair (TEER) System
Mitral TEERActive comparatorParticipants undergo isolated mitral transcatheter edge-to-edge repair for mitral regurgitation, accompanied by GDMT
Receives: Device: Transcatheter Edge-to-Edge Repair (TEER) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 months

Secondary outcomes (10)

  1. All-cause mortality

    all-cause mortality

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

  2. Cardiovascular mortality

    Cardiovascular mortality

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

  3. Incidence of surgical procedures due to mitral and/or tricuspid valve dysfunction

    Incidence of surgical procedures due to mitral and/or tricuspid valve dysfunction

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

  4. Incidence of interventional procedures due to mitral and/or tricuspid valve dysfunction

    Incidence of interventional procedures due to mitral and/or tricuspid valve dysfunction

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

  5. Incidence of heart failure rehospitalization

    Incidence of heart failure rehospitalization

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

  6. 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.

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

  7. 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.

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

  8. Quality of life of patients

    Changes in 6-minute walking distance

    Measured: Perioperative, 6 months, 12 months

  9. 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.

    Measured: Perioperative

  10. 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.

    Measured: Perioperative, 30 days, 6 months, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion28 Feb 2031 (estimated)
  4. Study completion31 Aug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
404 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07349888
Sponsor's protocol ID
KY20251223-08
Status last verified
Jan 2026
First submitted
8 Jan 2026
Last updated
20 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcatheter Edge-to-Edge Repair (TEER) System in people with Mitral Regurgitation and Tricuspid Regurgitation, run by Nanjing First Hospital, Nanjing Medical University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07349888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in