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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Secondary Outcome(s)
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Economic Measures (Inpatient Costs)
[Time Frame: up to 60 months]
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Survival
[Time Frame: up to 60 Months]
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Number of Participants With Serious Adverse Events
[Time Frame: 24 months]
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Pulmonary Artery Pressure
[Time Frame: up to 24 Months]
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Number of Participants With Degree of TR
[Time Frame: up to 24 Months]
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EuroQoL (EQ-5D)
[Time Frame: 24 Months]
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Six Minute Walk Test
[Time Frame: 24 Months]
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Length of Index Hospitalization
[Time Frame: average 30 days]
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Number of Participants With Readmission
[Time Frame: up to 24 months]
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Diuretic Use
[Time Frame: 24 Months]
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Number of Participants With NYHA Classification I-IV
[Time Frame: at 24 Months]
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Tricuspid Annular Peak Systolic Excursion (TAPSE)
[Time Frame: 24 Months]
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Peak Tricuspid Annular Velocity
[Time Frame: 24 Months]
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Right Ventricular Size
[Time Frame: 24 Months]
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Number of Participants With Normal RV Function
[Time Frame: up to 24 Months]
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Number of Participants With TV Reoperations
[Time Frame: up to 24 months]
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Gait Speed Test
[Time Frame: 24 months]
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Kansas City Cardiomyopathy Questionnaire (KCCQ)
[Time Frame: 24 Months]
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Right Ventricular Fractional Area Change (RVFAC)
[Time Frame: 24 Months]
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Right Ventricular Volume
[Time Frame: 24 Months]
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Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)
[Time Frame: up to 24 Months]
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SF-12
[Time Frame: 24 Months]
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