Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery

Conditions
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Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation

Intervention / Treatment
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* Procedure: TV Annuloplasty
* Procedure: MVS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MVS Alone<br>Participants will undergo mitral valve surgery alone. | Procedure: MVS<br>* MVS will be performed using standard surgical techniques<br>|
| Active Comparator: MVS + TV Annuloplasty<br>Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. | Procedure: TV Annuloplasty<br>* TV Annuloplasty will be performed using standard surgical techniques<br>Procedure: MVS<br>* MVS will be performed using standard surgical techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. 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. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients. No NYHA class listed or unable to determine | at 24 Months | 
| Diuretic Use | The diuretic requirements of patients will be assessed. | 24 Months | 
| Six Minute Walk Test | The total distance, in feet, walked in six minutes | 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. | up to 24 Months | 
| Right Ventricular Size |  | 24 Months | 
| Number of Participants With Normal RV Function | Number of Participants with Normal RV Function assessed by echocardiography. | up to 24 Months | 
| Peak Tricuspid Annular Velocity |  | 24 Months | 
| Tricuspid Annular Peak Systolic Excursion (TAPSE) | Degree of RV function assessed by TAPSE | 24 Months | 
| Right Ventricular Fractional Area Change (RVFAC) | Degree of RV function assessed by RVFAC | 24 Months | 
| Pulmonary Artery Pressure | Pulmonary artery pressure assessed by echocardiography. | up to 24 Months | 
| Right Ventricular Volume | RV Volume as measured by transthoracic 3D echocardiography. | 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. | 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. | 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. | 24 Months | 
| Survival | Incidence of participants alive | up to 60 Months | 
| Length of Index Hospitalization |  | average 30 days | 
| Number of Participants With Readmission | Incidence of readmissions | up to 24 months | 
| Number of Participants With TV Reoperations | Number of participants with TV reoperations | up to 24 months | 
| Economic Measures (Inpatient Costs) | Inpatient costs will be measured through the collection of hospital billing. | up to 60 months | 
| Number of Participants With Serious Adverse Events | Safety as measured by frequency of serious adverse events. | 24 months | 
| Gait Speed Test | Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tricuspid Valve Regurgitation