Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
- Conditions
- Mild Tricuspid RegurgitationTricuspid RegurgitationModerate Tricuspid Regurgitation
- Interventions
- Procedure: TV AnnuloplastyProcedure: MVS
- Registration Number
- NCT02675244
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- Brief 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.
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 401
-
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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MVS + TV Annuloplasty MVS Patients will undergo mitral valve surgery and tricuspid valve annuloplasty. MVS Alone MVS Participants will undergo mitral valve surgery alone. MVS + TV Annuloplasty TV Annuloplasty Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Treatment Failure 24 Months 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.
- Secondary Outcome Measures
Name Time Method Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) up to 24 Months 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
Number of Participants With NYHA Classification I-IV at 24 Months 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 determineSix Minute Walk Test 24 Months The total distance, in feet, walked in six minutes
Peak Tricuspid Annular Velocity 24 Months Diuretic Use 24 Months The diuretic requirements of patients will be assessed.
Number of Participants With Degree of TR up to 24 Months Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.
Right Ventricular Fractional Area Change (RVFAC) 24 Months Degree of RV function assessed by RVFAC
Length of Index Hospitalization average 30 days Number of Participants With Readmission up to 24 months Incidence of readmissions
Right Ventricular Size 24 Months Number of Participants With Normal RV Function up to 24 Months Number of Participants with Normal RV Function assessed by echocardiography.
Right Ventricular Volume 24 Months RV Volume as measured by transthoracic 3D echocardiography.
EuroQoL (EQ-5D) 24 Months 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.
SF-12 24 Months 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.
Number of Participants With TV Reoperations up to 24 months Number of participants with TV reoperations
Economic Measures (Inpatient Costs) up to 60 months Inpatient costs will be measured through the collection of hospital billing.
Tricuspid Annular Peak Systolic Excursion (TAPSE) 24 Months Degree of RV function assessed by TAPSE
Pulmonary Artery Pressure up to 24 Months Pulmonary artery pressure assessed by echocardiography.
Kansas City Cardiomyopathy Questionnaire (KCCQ) 24 Months 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.
Survival up to 60 Months Incidence of participants alive
Gait Speed Test 24 months Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks
Number of Participants With Serious Adverse Events 24 months Safety as measured by frequency of serious adverse events.
Trial Locations
- Locations (40)
Emory University
🇺🇸Atlanta, Georgia, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Mission Hospital
🇺🇸Asheville, North Carolina, United States
WakeMed Clinical Research Institute
🇺🇸Raleigh, North Carolina, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Stony Brook Hospital
🇺🇸Stony Brook, New York, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Duke University
🇺🇸Durham, North Carolina, United States
London Health Sciences
🇨🇦London, Ontario, Canada
Hôpital du Sacré-Cœur de Montréal
🇨🇦Montreal, Quebec, Canada
University Medical Center Göttingen
🇩🇪Göttingen, Lower Saxony, Germany
HDZ NRW Bad Oeynhausen
🇩🇪Bad Oeynhausen, Germany
Stanford University School of Medicine
🇺🇸Stanford, California, United States
MedStar Health
🇺🇸Columbia, Maryland, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
University of Virginia Health Systems
🇺🇸Charlottesville, Virginia, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada
University of Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
University Medical Center Jena
🇩🇪Jena, Thuringia, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Heart Center, University of Freiburg
🇩🇪Freiburg, Germany
Universitares Herzzentrum Hamburg
🇩🇪Berlin, Brandenburg, Germany
Herzzentrum Leipzig
🇩🇪Berlin, Brandenburg, Germany
Institut Universitaire de Cardiologie de Quebec (Hopital Laval)
🇨🇦Quebec, Canada
University Hospital Frankfurt
🇩🇪Frankfurt, Hesse-Nassau, Germany
German Heart Center Munich
🇩🇪Munich, Germany
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Baylor Research Institute
🇺🇸Plano, Texas, United States
University of Southern California
🇺🇸Los Angeles, California, United States
Yale University School of Medicine - Yale-New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Suburban Hospital
🇺🇸Bethesda, Maryland, United States
University of Michigan Health Services
🇺🇸Ann Arbor, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Montefiore Einstein Heart Center
🇺🇸Bronx, New York, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada