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Mild Tricuspid RegurgitationNCT02675244

Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

A study testing TV Annuloplasty and MVS in people with Mild Tricuspid Regurgitation and Moderate Tricuspid Regurgitation, run by Icahn School of Medicine at Mount Sinai at 41 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TV Annuloplasty and MVS
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
401 participants
Where
41 sitesin 3 countries
Study dates
26 May 2016to 19 Apr 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Undergoing MVS for degenerative MR* with (a) Moderate TR as determined by transthoracic 2D echocardiography, or (b) Tricuspid annular dimension ≥ 40 mm (index: ≥21mm/M2 BSA) and none/trace or mild TR, determined by echocardiography.
  • Age ≥ 18 years
  • Able to sign Informed Consent and Release of Medical Information forms
  • "Degenerative mitral valve disease refers to a spectrum of conditions in which morphologic changes in the connective tissues of the mitral valve cause structural lesions . . ., such as chordal elongation, chordal rupture, leaflet tissue expansion, and annular dilation typically resulting in mitral regurgitation due to leaflet prolapse." This definition excludes rheumatic heart disease. (Anyanwu AC, Adams DH. (2007) Etiological classification of degenerative mitral valve disease: Barlow's disease and fibroelasticity deficiency. Semin Thorac Cardiovasc Surg; 19(2): 90-6).

Who cannot join

  • Functional MR
  • Evidence of sub-optimal fluid management (e.g., lack of diuretics, weight in excess of dry weight) in the opinion of the cardiology investigator
  • Structural / organic TV disease
  • Severe TV regurgitation as determined by preoperative transthoracic echocardiography (TTE)
  • Implanted pacemaker or defibrillator, where the leads cross the TV from the right atrium into the right ventricle
  • Concomitant cardiac surgery other than atrial fibrillation correction surgery (PVI, Maze, LAA closure), closure of PFO or ASD, or CABG
Show all 15Show fewer
  • Cardiogenic shock at the time of randomization
  • STEMI requiring intervention within 7 days prior to randomization
  • Evidence of cirrhosis or hepatic synthetic failure
  • Severe, irreversible pulmonary hypertension in the judgment of the investigator
  • Pregnancy at the time of randomization
  • Therapy with an investigational intervention at the time of screening, or plan to enroll patient in additional investigational intervention study during participation in this trial
  • Any concurrent disease with life expectancy < 2 years
  • Unable or unwilling to provide informed consent
  • Unable or unwilling to comply with study follow up in the opinion of the investigator

Trial locations and contacts

41 sites in 3 countries.

41 sites in 3 countries

United States24 sites

  • University of Michigan Health Services

    Ann Arbor, Michigan, 48109

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Emory University

    Atlanta, Georgia, 30308

  • University of Maryland

    Baltimore, Maryland, 21201

  • Suburban Hospital

    Bethesda, Maryland, 20814

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22908

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • MedStar Health

    Columbia, Maryland, 21044

  • Ohio State University

    Columbus, Ohio, 43210

  • Duke University

    Durham, North Carolina, 27710

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Baylor College of Medicine

    Houston, Texas

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03766

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Yale University School of Medicine - Yale-New Haven Hospital

    New Haven, Connecticut, 06520-8039

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Baylor Research Institute

    Plano, Texas, 75093

  • WakeMed Clinical Research Institute

    Raleigh, North Carolina, 27610

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Stony Brook Hospital

    Stony Brook, New York, 11790

  • Montefiore Einstein Heart Center

    The Bronx, New York, 10467

Other trials in United States

Germany9 sites

  • HDZ NRW Bad Oeynhausen

    Bad Oeynhausen

  • Universitares Herzzentrum Hamburg

    Berlin, Brandenburg, 11353

  • Herzzentrum Leipzig

    Berlin, Brandenburg, 13347

  • Deutsches Herzzentrum Berlin

    Berlin

  • University Hospital Frankfurt

    Frankfurt, Hesse-Nassau, 60590

  • Heart Center, University of Freiburg

    Freiburg im Breisgau

  • University Medical Center Göttingen

    Göttingen, Lower Saxony

  • University Medical Center Jena

    Jena, Thuringia

  • German Heart Center Munich

    Munich

Other trials in Germany

Canada8 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G2B7

  • London Health Sciences

    London, Ontario, N6A 5A5

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Centre Hospitalier de l'Université de Montréal

    Montreal, Quebec, H2W 1T8

  • Hôpital du Sacré-Cœur de Montréal

    Montreal, Quebec, H4J 1C5

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • Institut Universitaire de Cardiologie de Quebec (Hopital Laval)

    Québec, Quebec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

The purpose of the research is to determine whether repairing a tricuspid valve (TV) in patients with mild to moderate tricuspid regurgitation (TR), at the time of planned mitral valve surgery (MVS), would improve the heart health of those who receive it compared to those who do not.

At this point, the medical community is split in their opinion on whether surgeons should routinely repair mild to moderate TR in patients who are undergoing planned mitral valve surgery, and this study will answer this question.

Read the detailed description

The tricuspid valve controls the flow of blood in your heart between the right ventricle and the right atrium. TR is a condition where the valve does not close fully when it is supposed to and blood can then leak back into the right atrium. When TR becomes severe, surgery is usually performed to correct it. The purpose of the research is to determine whether repairing a tricuspid valve in patients with mild to moderate TR, at the time of planned mitral valve surgery, would improve the heart health of those who receive it compared to those who do not. There are no new or "experimental" procedures being tested in this study: both the mitral valve procedure and the tricuspid valve repair procedure are well established surgeries and are regularly performed together in patients who have severe TR. The available evidence addressing this issue is not definite: it is based on less rigorous methods of investigation, and the results have been conflicting. The study being proposed here will use rigorous scientific methods and should result in a very high level of certainty about what surgical treatment is best for patients with your condition.

This study will enroll people scheduled for mitral valve surgery with mild to moderate tricuspid regurgitation.

Being tested
TV Annuloplasty, MVS
Keywords
Tricuspid Valve Regurgitation
Medical subject headings
Tricuspid Valve Insufficiency

What participants receive

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

  • TV AnnuloplastyProcedure or surgery

    TV Annuloplasty will be performed using standard surgical techniques

  • MVSProcedure or surgery

    MVS will be performed using standard surgical techniques

Study groups in NCT02675244
Study groupRoleWhat they receive
MVS AloneActive comparatorParticipants will undergo mitral valve surgery alone.
Receives: Procedure: MVS
MVS + TV AnnuloplastyActive comparatorPatients will undergo mitral valve surgery and tricuspid valve annuloplasty.
Receives: Procedure: TV Annuloplasty; Procedure: MVS

What is being measured

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

  1. Percentage of Participants With Treatment Failure

    The primary outcome of this trial is treatment failure defined as the composite of (1) death from any cause, (2) reoperation for TR, (3) presence of severe TR at two years post randomization or, for patients enrolled with less than moderate TR and annular dilatation, progression by two grades (i.e., from none/trace TR to moderate TR) at two years post randomization.

    Measured: 24 Months

Secondary outcomes (22)

  1. Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Major Adverse Cardiac and Cerebrovascular Events (MACCE) is defined as a non-weighted composite score comprised of the following components: Death, Stroke, and Serious heart failure events

    Measured: up to 24 Months

  2. Number of Participants With NYHA Classification I-IV

    Functional status will be assessed by the New York Heart Association (NYHA) Classification scale which ranges from 1 (no physical limitations) to 4 (severe limitation of physical activity).

    1. Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc.
    2. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
    3. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest.
    4. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
    5. No NYHA class listed or unable to determine

    Measured: at 24 Months

  3. Diuretic Use

    The diuretic requirements of patients will be assessed.

    Measured: 24 Months

  4. Six Minute Walk Test

    The total distance, in feet, walked in six minutes

    Measured: 24 Months

  5. Number of Participants With Degree of TR

    Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.

    Measured: up to 24 Months

  6. Right Ventricular Size

    Measured: 24 Months

  7. Number of Participants With Normal RV Function

    Number of Participants with Normal RV Function assessed by echocardiography.

    Measured: up to 24 Months

  8. Peak Tricuspid Annular Velocity

    Measured: 24 Months

  9. Tricuspid Annular Peak Systolic Excursion (TAPSE)

    Degree of RV function assessed by TAPSE

    Measured: 24 Months

  10. Right Ventricular Fractional Area Change (RVFAC)

    Degree of RV function assessed by RVFAC

    Measured: 24 Months

  11. Pulmonary Artery Pressure

    Pulmonary artery pressure assessed by echocardiography.

    Measured: up to 24 Months

  12. Right Ventricular Volume

    RV Volume as measured by transthoracic 3D echocardiography.

    Measured: 24 Months

  13. SF-12

    Quality of Life assessed by SF-12. A measure of perceived health (health-related quality of life [QoL]) that describes the degree of general physical health status and mental health distress. Higher scores indicate higher levels of health. The physical and mental health scores on the 12-Item Short Form Survey (SF-12) are reported as T scores (mean, 50±10, 50 indicates the population mean with a standard deviation of 10), with higher scores indicating better health status.

    Measured: 24 Months

  14. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Quality of Life assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ). KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life, in which higher scores reflect better health status. Scores on the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary range from 0 to 100, with higher scores indicating a better quality of life and fewer symptoms and physical limitations associated with heart failure.

    Measured: 24 Months

  15. EuroQoL (EQ-5D)

    Quality of Life assessed by EuroQoL (EQ-5D) - a standardised instrument for use as a measure of health outcome. Scores on the EuroQol (EQ-5D) visual analogue scale range from 0 (worst imaginable health) to 100 (best imaginable health). Higher scores indicate higher levels of health.

    Measured: 24 Months

  16. Survival

    Incidence of participants alive

    Measured: up to 60 Months

  17. Length of Index Hospitalization

    Measured: average 30 days

  18. Number of Participants With Readmission

    Incidence of readmissions

    Measured: up to 24 months

  19. Number of Participants With TV Reoperations

    Number of participants with TV reoperations

    Measured: up to 24 months

  20. Economic Measures (Inpatient Costs)

    Inpatient costs will be measured through the collection of hospital billing.

    Measured: up to 60 months

  21. Number of Participants With Serious Adverse Events

    Safety as measured by frequency of serious adverse events.

    Measured: 24 months

  22. Gait Speed Test

    Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks

    Measured: 24 months

Timeline

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

  1. First posted5 Feb 2016 (estimated)
  2. Study start26 May 2016
  3. Primary completion19 Apr 2021
  4. Study completion19 Apr 2021

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
401 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02675244
Sponsor's protocol ID
GCO 08-1078-0010
Other IDs
2U01HL088942-07
Status last verified
May 2024
First submitted
29 Jan 2016
Last updated
18 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Chu MWA, Raymond S, Gelijns AC, Moskowitz AJ, Borger MA, Mack M, Hung J, Voisine P, Gammie JS, Krane M, Yerokun BA, Bowdish ME, Conradi L, Bolling SF, Taddei-Peters WC, Jeffries NO, Marks ME, Gupta L, Iribarne A, Beyersdorf F, Bagiella E, Geirsson A, Overbey JR, Gillinov M, O'Gara PT, Ailawadi G, Falk V. Mitral Valve Repair for Degenerative MR With Moderate or Less Tricuspid Regurgitation: 2-Year Outcomes From a Multicenter Echocardiographic Core Laboratory-Adjudicated Cohort. J Am Coll Cardiol. 2026 Jun 23;87(24):3436-3448. doi: 10.1016/j.jacc.2025.12.065. Epub 2026 Feb 18.

    PubMed 41706073

  • Ailawadi G, Voisine P, Raymond S, Gelijns AC, Moskowitz AJ, Falk V, Overbey JR, Chu MWA, Mack MJ, Bowdish ME, Krane M, Yerokun B, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Fenton KN, Jeffries NO, Kramer RS, Geirsson A, Moquete EG, O'Sullivan K, Hupf J, Hung J, Beyersdorf F, Bagiella E, Gammie JS, O'Gara PT, Iribarne A, Borger MA, Gillinov M; trial investigators. Pacemaker implantation associated with tricuspid repair in the setting of mitral valve surgery: Insights from a Cardiothoracic Surgical Trials Network randomized trial. J Thorac Cardiovasc Surg. 2024 Jun;167(6):2104-2116.e5. doi: 10.1016/j.jtcvs.2022.11.031. Epub 2022 Dec 8.

    PubMed 36669972

  • Gammie JS, Chu MWA, Falk V, Overbey JR, Moskowitz AJ, Gillinov M, Mack MJ, Voisine P, Krane M, Yerokun B, Bowdish ME, Conradi L, Bolling SF, Miller MA, Taddei-Peters WC, Jeffries NO, Parides MK, Weisel R, Jessup M, Rose EA, Mullen JC, Raymond S, Moquete EG, O'Sullivan K, Marks ME, Iribarne A, Beyersdorf F, Borger MA, Geirsson A, Bagiella E, Hung J, Gelijns AC, O'Gara PT, Ailawadi G; CTSN Investigators. Concomitant Tricuspid Repair in Patients with Degenerative Mitral Regurgitation. N Engl J Med. 2022 Jan 27;386(4):327-339. doi: 10.1056/NEJMoa2115961. Epub 2021 Nov 13.

    PubMed 34767705

Questions about this trial

What is this clinical trial studying?

A study testing TV Annuloplasty and MVS in people with Mild Tricuspid Regurgitation and Moderate Tricuspid Regurgitation, run by Icahn School of Medicine at Mount Sinai at 41 sites in 3 countries.

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 4 inclusion and 15 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: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 21 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Treatment Failure (time frame: 24 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 NCT02675244, which also lists 3 linked publications.

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 18 Jun 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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