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.
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.
Brief Title
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
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.
This study will enroll people scheduled for mitral valve surgery with mild to moderate tricuspid regurgitation.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Mild Tricuspid Regurgitation
Moderate Tricuspid Regurgitation
Tricuspid Regurgitation
Eligibility Criteria
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
* 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
Inclusion Criteria
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).
* 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).
Gender
All
Gender Based
false
Keywords
Tricuspid Valve Regurgitation
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02675244
Org Class
Other
Org Full Name
Icahn School of Medicine at Mount Sinai
Org Study Id
GCO 08-1078-0010
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Participants With Treatment Failure
Outcome Time Frame
24 Months
Secondary Ids
Secondary Id
2U01HL088942-07
Secondary Outcomes
Outcome Description
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
Outcome Time Frame
up to 24 Months
Outcome Measure
Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Outcome Description
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
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
Outcome Time Frame
at 24 Months
Outcome Measure
Number of Participants With NYHA Classification I-IV
Outcome Description
The diuretic requirements of patients will be assessed.
Outcome Time Frame
24 Months
Outcome Measure
Diuretic Use
Outcome Description
The total distance, in feet, walked in six minutes
Outcome Time Frame
24 Months
Outcome Measure
Six Minute Walk Test
Outcome Description
Degree of TR assessed by echocardiography, categorized according to American Society of Echocardiography guidelines as none/mild/moderate/severe.
Outcome Time Frame
up to 24 Months
Outcome Measure
Number of Participants With Degree of TR
Outcome Time Frame
24 Months
Outcome Measure
Right Ventricular Size
Outcome Description
Number of Participants with Normal RV Function assessed by echocardiography.
Outcome Time Frame
up to 24 Months
Outcome Measure
Number of Participants With Normal RV Function
Outcome Time Frame
24 Months
Outcome Measure
Peak Tricuspid Annular Velocity
Outcome Description
Degree of RV function assessed by TAPSE
Outcome Time Frame
24 Months
Outcome Measure
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Outcome Description
Degree of RV function assessed by RVFAC
Outcome Time Frame
24 Months
Outcome Measure
Right Ventricular Fractional Area Change (RVFAC)
Outcome Description
Pulmonary artery pressure assessed by echocardiography.
Outcome Time Frame
up to 24 Months
Outcome Measure
Pulmonary Artery Pressure
Outcome Description
RV Volume as measured by transthoracic 3D echocardiography.
Outcome Time Frame
24 Months
Outcome Measure
Right Ventricular Volume
Outcome Description
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.
Outcome Time Frame
24 Months
Outcome Measure
SF-12
Outcome Description
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.
Outcome Time Frame
24 Months
Outcome Measure
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Outcome Description
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.
Outcome Time Frame
24 Months
Outcome Measure
EuroQoL (EQ-5D)
Outcome Description
Incidence of participants alive
Outcome Time Frame
up to 60 Months
Outcome Measure
Survival
Outcome Time Frame
average 30 days
Outcome Measure
Length of Index Hospitalization
Outcome Description
Incidence of readmissions
Outcome Time Frame
up to 24 months
Outcome Measure
Number of Participants With Readmission
Outcome Description
Number of participants with TV reoperations
Outcome Time Frame
up to 24 months
Outcome Measure
Number of Participants With TV Reoperations
Outcome Description
Inpatient costs will be measured through the collection of hospital billing.
Outcome Time Frame
up to 60 months
Outcome Measure
Economic Measures (Inpatient Costs)
Outcome Description
Safety as measured by frequency of serious adverse events.
Outcome Time Frame
24 months
Outcome Measure
Number of Participants With Serious Adverse Events
Outcome Description
Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks
Outcome Time Frame
24 months
Outcome Measure
Gait Speed Test
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Robert Michler
Investigator Email
RMICHLER@MONTEFIORE.ORG
Investigator Phone
rmichler