Mild Tricuspid Regurgitation, Moderate Tricuspid Regurgitation, Tricuspid Regurgitation
Conditions
Keywords
Tricuspid Valve Regurgitation
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.
Interventions
PROCEDURETV Annuloplasty
TV Annuloplasty will be performed using standard surgical techniques
PROCEDUREMVS
MVS will be performed using standard surgical techniques
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
German Society for Thoracic and Cardiovascular Surgery
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 determine |
| Diuretic Use | 24 Months | The diuretic requirements of patients will be assessed. |
| Six Minute Walk Test | 24 Months | The total distance, in feet, walked in six minutes |
| 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 Size | 24 Months | — |
| Number of Participants With Normal RV Function | up to 24 Months | Number of Participants with Normal RV Function assessed by echocardiography. |
| Peak Tricuspid Annular Velocity | 24 Months | — |
| Tricuspid Annular Peak Systolic Excursion (TAPSE) | 24 Months | Degree of RV function assessed by TAPSE |
| Right Ventricular Fractional Area Change (RVFAC) | 24 Months | Degree of RV function assessed by RVFAC |
| Pulmonary Artery Pressure | up to 24 Months | Pulmonary artery pressure assessed by echocardiography. |
| 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 |
| 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. |
| 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. |
| 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. |
| Survival | up to 60 Months | Incidence of participants alive |
| Length of Index Hospitalization | average 30 days | — |
| Number of Participants With Readmission | up to 24 months | Incidence of readmissions |
| 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. |
| Number of Participants With Serious Adverse Events | 24 months | Safety as measured by frequency of serious adverse events. |
| Gait Speed Test | 24 months | Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks |
| Right Ventricular Volume | 24 Months | RV Volume as measured by transthoracic 3D echocardiography. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
From 2016 through 2018, a total of 5208 patients were screened; 885 were eligible to participate in the trial, and 401 underwent randomization
Participants by arm
| Arm | Count |
|---|---|
| MVS Alone Participants will undergo mitral valve surgery alone.
MVS: MVS will be performed using standard surgical techniques | 203 |
| MVS + TV Annuloplasty Patients will undergo mitral valve surgery and tricuspid valve annuloplasty.
TV Annuloplasty: TV Annuloplasty will be performed using standard surgical techniques
MVS: MVS will be performed using standard surgical techniques | 198 |
| Total | 401 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 9 | 6 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Ongoing at 2 Years | 190 | 185 |
| Overall Study | Withdrawal by Subject | 3 | 6 |
Baseline characteristics
| Characteristic | MVS Alone | Total | MVS + TV Annuloplasty |
|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 9.7 | 67.4 years STANDARD_DEVIATION 10.3 | 66.6 years STANDARD_DEVIATION 10.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 192 Participants | 379 Participants | 187 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 16 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 8 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 10 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 15 Participants | 9 Participants |
| Race (NIH/OMB) White | 184 Participants | 366 Participants | 182 Participants |
| Region of Enrollment Canada | 43 participants | 87 participants | 44 participants |
| Region of Enrollment Germany | 44 participants | 78 participants | 34 participants |
| Region of Enrollment United States | 116 participants | 236 participants | 120 participants |
| Sex: Female, Male Female | 50 Participants | 101 Participants | 51 Participants |
| Sex: Female, Male Male | 153 Participants | 300 Participants | 147 Participants |
| Tricuspid Regurgitation Moderate | 76 Participants | 149 Participants | 73 Participants |
| Tricuspid Regurgitation < Moderate | 126 Participants | 250 Participants | 124 Participants |
| Tricuspid Regurgitation Unable to assess | 1 Participants | 2 Participants | 1 Participants |
| Tricuspid-valve annulus dimension (mm) | 42.2 mm STANDARD_DEVIATION 4.7 | 42.1 mm STANDARD_DEVIATION 4.6 | 42.0 mm STANDARD_DEVIATION 4.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 9 / 203 | 6 / 198 |
| other Total, other adverse events | 74 / 203 | 61 / 198 |
| serious Total, serious adverse events | 109 / 203 | 109 / 198 |
Outcome results
Primary
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.
Time frame: 24 Months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MVS Alone | Percentage of Participants With Treatment Failure | 10.2 percentage of participants |
| MVS + TV Annuloplasty | Percentage of Participants With Treatment Failure | 3.9 percentage of participants |
Secondary
Diuretic Use
The diuretic requirements of patients will be assessed.
Time frame: 24 Months
Population: Patients with known diuretic status at 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVS Alone | Diuretic Use | 55 Participants |
| MVS + TV Annuloplasty | Diuretic Use | 41 Participants |
Secondary
Economic Measures (Inpatient Costs)
Inpatient costs will be measured through the collection of hospital billing.
Time frame: up to 60 months
Secondary
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.
Time frame: 24 Months
Population: Patients with observed Euro-QOL
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVS Alone | EuroQoL (EQ-5D) | 81.6 score on a scale | Standard Deviation 15.6 |
| MVS + TV Annuloplasty | EuroQoL (EQ-5D) | 84.0 score on a scale | Standard Deviation 13 |
Secondary
Gait Speed Test
Frailty will be assessed using the Gait Speed Test, which measures the average speed of three 5 meter walks
Time frame: 24 months
Population: Patients with observed gait speed test at 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MVS Alone | Gait Speed Test | 1.3 m/s |
| MVS + TV Annuloplasty | Gait Speed Test | 1.3 m/s |
Secondary
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.
Time frame: 24 Months
Population: Patients with observed KCCQ at 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MVS Alone | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 88.0 score on a scale | Standard Deviation 16.5 |
| MVS + TV Annuloplasty | Kansas City Cardiomyopathy Questionnaire (KCCQ) | 90.3 score on a scale | Standard Deviation 14.8 |
Secondary
Length of Index Hospitalization
Time frame: average 30 days
Population: Post-surgery hospital LOS between treatment groups compared, separately by region. 1 Canadian patient in the MVS+TA group withdrew prior to discharge from the index hospitalization so do not have their LOS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MVS Alone | Length of Index Hospitalization | 6 days |
| MVS + TV Annuloplasty | Length of Index Hospitalization | 8 days |
| MVS Alone - Canada | Length of Index Hospitalization | 7 days |
| MVS + TA - Canada | Length of Index Hospitalization | 9 days |
| MVS Alone - Germany | Length of Index Hospitalization | 11.5 days |
| MVS + TA - Germany | Length of Index Hospitalization | 12 days |
Secondary
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.
Time frame: up to 24 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVS Alone | Number of Participants With Degree of TR | None/Trace | 75 Participants |
| MVS Alone | Number of Participants With Degree of TR | Died | 9 Participants |
| MVS Alone | Number of Participants With Degree of TR | Moderate | 35 Participants |
| MVS Alone | Number of Participants With Degree of TR | Withdrew/LTF | 4 Participants |
| MVS Alone | Number of Participants With Degree of TR | Mild | 59 Participants |
| MVS Alone | Number of Participants With Degree of TR | Missed Assessment | 11 Participants |
| MVS Alone | Number of Participants With Degree of TR | Severe | 10 Participants |
| MVS + TV Annuloplasty | Number of Participants With Degree of TR | Missed Assessment | 6 Participants |
| MVS + TV Annuloplasty | Number of Participants With Degree of TR | None/Trace | 150 Participants |
| MVS + TV Annuloplasty | Number of Participants With Degree of TR | Mild | 23 Participants |
| MVS + TV Annuloplasty | Number of Participants With Degree of TR | Moderate | 5 Participants |
| MVS + TV Annuloplasty | Number of Participants With Degree of TR | Severe | 1 Participants |
| MVS + TV Annuloplasty | Number of Participants With Degree of TR | Died | 6 Participants |
| MVS + TV Annuloplasty | Number of Participants With Degree of TR | Withdrew/LTF | 7 Participants |
Secondary
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
Time frame: up to 24 Months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVS Alone | Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 23 Participants |
| MVS + TV Annuloplasty | Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE) | 20 Participants |
Secondary
Number of Participants With Normal RV Function
Number of Participants with Normal RV Function assessed by echocardiography.
Time frame: up to 24 Months
Population: Patients with observed RV Function at 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVS Alone | Number of Participants With Normal RV Function | 163 Participants |
| MVS + TV Annuloplasty | Number of Participants With Normal RV Function | 162 Participants |
Secondary
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
Time frame: at 24 Months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MVS Alone | Number of Participants With NYHA Classification I-IV | Class III | 5 Participants |
| MVS Alone | Number of Participants With NYHA Classification I-IV | Died | 9 Participants |
| MVS Alone | Number of Participants With NYHA Classification I-IV | Class II | 24 Participants |
| MVS Alone | Number of Participants With NYHA Classification I-IV | Withdrew/LTF | 4 Participants |
| MVS Alone | Number of Participants With NYHA Classification I-IV | Class IV | 0 Participants |
| MVS Alone | Number of Participants With NYHA Classification I-IV | Missed Assessment | 11 Participants |
| MVS Alone | Number of Participants With NYHA Classification I-IV | Class I | 150 Participants |
| MVS + TV Annuloplasty | Number of Participants With NYHA Classification I-IV | Missed Assessment | 6 Participants |
| MVS + TV Annuloplasty | Number of Participants With NYHA Classification I-IV | Class I | 155 Participants |
| MVS + TV Annuloplasty | Number of Participants With NYHA Classification I-IV | Class II | 22 Participants |
| MVS + TV Annuloplasty | Number of Participants With NYHA Classification I-IV | Class III | 2 Participants |
| MVS + TV Annuloplasty | Number of Participants With NYHA Classification I-IV | Class IV | 0 Participants |
| MVS + TV Annuloplasty | Number of Participants With NYHA Classification I-IV | Died | 6 Participants |
| MVS + TV Annuloplasty | Number of Participants With NYHA Classification I-IV | Withdrew/LTF | 7 Participants |
Secondary
Number of Participants With Readmission
Incidence of readmissions
Time frame: up to 24 months
Population: \*2 patients in the MVS alone and 3 patients in the MVS+TA group died during the index hospitalization, 1 patient in the MVS+TA group withdrew prior to discharge from the index hospitalization - these patients are excluded from analyses of readmission by 2 years post-randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVS Alone | Number of Participants With Readmission | 66 Participants |
| MVS + TV Annuloplasty | Number of Participants With Readmission | 69 Participants |
Secondary
Number of Participants With Serious Adverse Events
Safety as measured by frequency of serious adverse events.
Time frame: 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVS Alone | Number of Participants With Serious Adverse Events | 109 Participants |
| MVS + TV Annuloplasty | Number of Participants With Serious Adverse Events | 109 Participants |
Secondary
Number of Participants With TV Reoperations
Number of participants with TV reoperations
Time frame: up to 24 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MVS Alone | Number of Participants With TV Reoperations | 0 Participants |
| MVS + TV Annuloplasty | Number of Participants With TV Reoperations | 0 Participants |
Secondary
Peak Tricuspid Annular Velocity
Time frame: 24 Months
Secondary
Pulmonary Artery Pressure
Pulmonary artery pressure assessed by echocardiography.
Time frame: up to 24 Months
Secondary
Right Ventricular Fractional Area Change (RVFAC)
Degree of RV function assessed by RVFAC
Time frame: 24 Months
Secondary
Right Ventricular Size
Time frame: 24 Months
Secondary
Right Ventricular Volume
RV Volume as measured by transthoracic 3D echocardiography.
Time frame: 24 Months
Secondary
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.
Time frame: 24 Months
Population: Patients with observed SF-12 at 24 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MVS Alone | SF-12 | Physical Health | 47.5 T-Score | Standard Deviation 10 |
| MVS Alone | SF-12 | Mental Health | 54.1 T-Score | Standard Deviation 9 |
| MVS + TV Annuloplasty | SF-12 | Physical Health | 49.1 T-Score | Standard Deviation 9.1 |
| MVS + TV Annuloplasty | SF-12 | Mental Health | 54.3 T-Score | Standard Deviation 8.3 |
Secondary
Six Minute Walk Test
The total distance, in feet, walked in six minutes
Time frame: 24 Months
Population: Patients with observed 6MWT at 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| MVS Alone | Six Minute Walk Test | 1440 feet |
| MVS + TV Annuloplasty | Six Minute Walk Test | 1515 feet |
Secondary
Survival
Incidence of participants alive
Time frame: up to 60 Months
Secondary
Tricuspid Annular Peak Systolic Excursion (TAPSE)
Degree of RV function assessed by TAPSE
Time frame: 24 Months