Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 75
- 主要终点
- Percentage of Participants With Treatment Failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Percentage of Participants With Treatment Failure
时间窗: 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.
次要结局
- Number of Participants With Major Adverse Cardiac and Cerebrovascular Events (MACCE)(up to 24 Months)
- Number of Participants With NYHA Classification I-IV(at 24 Months)
- Six Minute Walk Test(24 Months)
- Peak Tricuspid Annular Velocity(24 Months)
- Diuretic Use(24 Months)
- Number of Participants With Degree of TR(up to 24 Months)
- Right Ventricular Fractional Area Change (RVFAC)(24 Months)
- Length of Index Hospitalization(average 30 days)
- Number of Participants With Readmission(up to 24 months)
- Right Ventricular Size(24 Months)
- EuroQoL (EQ-5D)(24 Months)
- Number of Participants With Normal RV Function(up to 24 Months)
- Right Ventricular Volume(24 Months)
- SF-12(24 Months)
- Number of Participants With TV Reoperations(up to 24 months)
- Economic Measures (Inpatient Costs)(up to 60 months)
- Tricuspid Annular Peak Systolic Excursion (TAPSE)(24 Months)
- Pulmonary Artery Pressure(up to 24 Months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ)(24 Months)
- Survival(up to 60 Months)
- Gait Speed Test(24 months)
- Number of Participants With Serious Adverse Events(24 months)
研究者
Annetine Gelijns
Professor
Icahn School of Medicine at Mount Sinai