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

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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
Conditions the study is for: Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
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

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

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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.

Country

City, postcode or hospital

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

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.

Conditions: Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, 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 group	Role	What they receive
MVS Alone	Active comparator	Participants will undergo mitral valve surgery alone. Receives: Procedure: MVS
MVS + TV Annuloplasty	Active comparator	Patients 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.

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)

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
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
Diuretic Use
The diuretic requirements of patients will be assessed.
Measured: 24 Months
Six Minute Walk Test
The total distance, in feet, walked in six minutes
Measured: 24 Months
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
Right Ventricular Size
Measured: 24 Months
Number of Participants With Normal RV Function
Number of Participants with Normal RV Function assessed by echocardiography.
Measured: up to 24 Months
Peak Tricuspid Annular Velocity
Measured: 24 Months
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Degree of RV function assessed by TAPSE
Measured: 24 Months
Right Ventricular Fractional Area Change (RVFAC)
Degree of RV function assessed by RVFAC
Measured: 24 Months
Pulmonary Artery Pressure
Pulmonary artery pressure assessed by echocardiography.
Measured: up to 24 Months
Right Ventricular Volume
RV Volume as measured by transthoracic 3D echocardiography.
Measured: 24 Months
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
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
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
Survival
Incidence of participants alive
Measured: up to 60 Months
Length of Index Hospitalization
Measured: average 30 days
Number of Participants With Readmission
Incidence of readmissions
Measured: up to 24 months
Number of Participants With TV Reoperations
Number of participants with TV reoperations
Measured: up to 24 months
Economic Measures (Inpatient Costs)
Inpatient costs will be measured through the collection of hospital billing.
Measured: up to 60 months
Number of Participants With Serious Adverse Events
Safety as measured by frequency of serious adverse events.
Measured: 24 months
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.

26 May 201619 Apr 2021

First posted5 Feb 2016 (estimated)
Study start26 May 2016
Primary completion19 Apr 2021
Study completion19 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Mild Tricuspid RegurgitationStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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
Results posted: Yes, on ClinicalTrials.gov
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