Echo-Guided Tricuspid Valve Surgery Vs. Conservative Approach At The Time Of Left- Sided Valve Surgery. A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 试验地点
- 8
- 主要终点
- Significant TR (moderate or severe)
研究概览
简要总结
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.
详细描述
The present study is designed as a prospective, multicentre, multinational, randomized, 2-arm parallel group trial. Participating centres are selected based on previous experience with the surgical technique and standardised echo imaging. Each center is expected to contribute 70 patients over a 12 months enrolment period.
Patients elected to undergo any type of left-sided valve surgery (either repair or replacement) with non severe tricuspid regurgitation and tricuspid annular dilation will be screened. Consenting patients fulfilling all inclusion and exclusion criteria will be included in the study and assigned to elective left-sided valve replacement or repair with or without concomitant tricuspid valve repair in a 1:1 fashion, using a blocked randomization scheme balanced within center.
After discharge patients will be assessed at 1, 12, 24 and 36 months after surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing left-sided valve surgery for left-sided valve disease
- •Presence of non-severe TR and tricuspid annular dilation (>40 mm or > 21 mm/m2 BSA) determined by echocardiography
- •Age ≥ 18 years
- •Capability to sign Informed Consent and Release of Medical Information forms
排除标准
- •Preoperative severe TR
- •Structural / organic tricuspid valve disease
- •Tricuspid annulus ≤40 mm (or ≤ 21 mm/m2 BSA) on preoperative TTE
- •Implanted pacemaker or defibrillator, where the leads cross the tricuspid valve from the right atrium into the RV
- •Any type of reoperative surgery
- •Concomitant cardiac surgery other than atrial fibrillation correction surgery (pulmonary vein isolation, Maze procedure, left atrial appendage closure) or closure of patent foramen ovale or atrial septal defect (for example, concomitant coronary artery bypass graft or aortic surgery)
- •Cardiogenic shock at the time of randomization
- •ST-elevated myocardial infarction 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
- •Any concurrent disease with life expectancy < 1 year
- •Patient unable or unwilling to provide informed consent
研究组 & 干预措施
Tricuspid Valve Repair
Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery
干预措施: Tricuspid Valve Repair (Procedure)
Tricuspid Valve Repair
Concomitant tricuspid valve repair in patients undergoing left-sided valve surgery
干预措施: Left-sided valve surgery (Procedure)
left-sided valve surgery
No concomitant tricuspid valve repair in patients in pts undergoing left-sided valve surgery
干预措施: Left-sided valve surgery (Procedure)
结局指标
主要结局
Significant TR (moderate or severe)
时间窗: 3 years
To compare in a prospective and randomized way the effect of two different strategies on significant TR (moderate or severe) in patients undergoing surgery for left heart valve disease of any type as assessed by the Core lab evaluation of the echocardiogram. In the echocardiogram images TR by jet area will be grouped as moderate (5-10 cm2) or severe (\>10 cm2).
次要结局
- Significant TR (moderate or severe)(1 and 2 years)
- Overall TR (mild, moderate, severe)(1, 2 and 3 years)
- Event free survival(3 years)
- Mild TR(1,2 and 3 years)
- RV function(1, 2 and 3 years)
- Pulmonary Artery Pressure (PAP)(1, 2 and 3 years)