A Prospective Randomized Trial Comparing the Surgical Treatment of Ischemic Mitral Regurgitation Versus Percutaneous Mitral Repair Followed by Surgical Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Hospitalization rate for congestive heart failure
研究概览
简要总结
Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients.
The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by coronary artery bypass grafting.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe ischemic Mitral regurgitation (MR), as defined by the 2017 American Society of Echocardiography (ASE) guidelines for noninvasive evaluation of native valvular regurgitation.
- •Presence of reversible myocardial ischemia confirmed by preoperative myocardial viability study using radionuclide imaging.
排除标准
- •Patients with mixed mitral valve pathology, including fibroelastic deficiency, rheumatic valve disease, ruptured mitral valve chordae, mitral valve endocarditis.
- •Patients with acute ischemic MR, defined as MR caused by papillary muscle infarction and rupture.
- •Age < 18 years.
- •Prohibitive surgical risk or contraindications to Cardiopulmonary bypass (CPB) as defined by the Heart Team.
- •Need for a concomitant surgical procedure, excluding Coronary artery bypass grafting (CABG), tricuspid valve repair, Patent foramen ovale (PFO) closure, Atrial septal defect (ASD) closure and Maze procedure.
- •Prior mitral valve repair procedure (percutaneous or surgical).
- •Leaflet anatomy unsuitable for MitraClip implantation, proper MitraClip positioning on the leaflets or sufficient reduction in MR by the MitraClip.
研究组 & 干预措施
Mitral valve surgery
Surgical mitral valve surgery +/- coronary artery bypass grafting
干预措施: Surgical mitral valve repair/replacement (Procedure)
Percutaneous mitral repair
Percutaneous mitral repair +/- coronary artery bypass grafting within 14 days of mitral repair.
干预措施: Percutaneous mitral valve repair (Procedure)
结局指标
主要结局
Hospitalization rate for congestive heart failure
时间窗: Within 12 months of intervention
Admission to hospital with congestive heart failure exacerbation being the primary reason for admission. Congestive heart failure exacerbation is defined as 1) evidence of fluid overload and elevated filling pressures (for example, a central venous pressure \> 8mmHg and/or a pulmonary capillary wedge pressure \> 18mmHg) and/or 2) new decrease in cardiac output (for example, cardiac index \< 2.2 L/min/m2) and end-organ perfusion (measured by one or more of: urine output \< 20mL/hr, lactate \>= 2.0, mixed venous oxygen saturation \< 70%).
Rate of myocardial infarction
时间窗: Within 12 months of intervention
These will be defined according to the Fourth Universal Definition of Myocardial Infarction
Mortality rate
时间窗: Within 12 months of intervention
All-cause mortality. Death from cardiovascular and non-cardiovascular causes.
Rate of Stroke
时间窗: Within 12 months of intervention
1\) New, acute focal neurological deficit thought to be of vascular origin with signs or symptoms lasting \> 24 h and confirmed by a neurologist or 2) new, focal neurological deficit lasting \> 24 h with imaging evidence of cerebral infarction or intracerebral hemorrhage.
次要结局
- Presence of recurrent MR ≥2+(Within 6 and12 months of intervention)
- Change in indexed left atrial volume(Within 6 and12 months of intervention)
- Rate of mitral valve re-intervention(Within12 months of intervention)
- Degree of left ventricular remodeling(Within 6 and12 months of intervention)
- Cumulative hospital days(Within 12-months of intervention)
- Number of Participants with worsening in heart failure symptoms(Within 6 and12 months of intervention)