Left Ventricular Papillary Muscle Sling for Heart Failure With Reduced Ejection Fraction (Papillary Muscle Sling)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in left ventricular function as assessed by LVEF
研究概览
简要总结
The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.
详细描述
The Sling is used to draw together the ventricular walls at the base of the papillary muscles. This technique has previously been used in conjunction with mitral valve surgery, and has shown significant benefits for the patients.
The reduction in the lateral inter-papillary muscle separation and in the left ventricular volume provided by this technique is expected to improve ventricular function, limit progression of ventricular dilation, and avoid progression of MR when performed without mitral valve surgery in patients with symptomatic ventricular dilation.
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 symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below:
- •Left ventricular end diastolic diameter is greater than or equal to 55mm.
- •Ejection fraction ≥20% and ≤40%
- •FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic or transesophageal echo).
- •End-systolic Interpapillary muscle distance ≥ 20mm
- •Cardiomyopathy of ischemic or non-ischemic origins.
- •Able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf.
排除标准
- •Any evidence of structural (chordal or leaflet) mitral lesions.
- •Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect or coronary revascularization)
- •Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation.
- •Persistent atrial fibrillation
- •Prior mitral valve repair
- •Contraindication for cardiopulmonary bypass
- •Clinical signs of cardiogenic shock
- •ST segment elevation myocardial infarction within 14 days prior to inclusion in this study.
- •Congenital heart disease (except PFO or ASD)
- •Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery
- •Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator
- •Pregnancy
结局指标
主要结局
Change in left ventricular function as assessed by LVEF
时间窗: Baseline, up to 5 years
Change in Left Ventricular Ejection Fraction (LVEF) will be reported as a change in percent ejection fraction assessed via echocardiogram
Change in left ventricular volume
时间窗: Baseline, up to 5 years
End systolic and end diastolic left ventricular volumes will both be evaluated in mL using echocardiogram.
次要结局
- Incidence of Mitral Leaflet Tenting(5 years)
- Mortality Rate(5 years)
- Number of Major Adverse Cardiac Events (MACE)(5 years)
- Percentage of participants at each FMR severity grade(Baseline, up to 5 years)
- All Cause Readmission Rate(5 years)
- Change in MLHF Questionnaire Score(Baseline, up to 5 years)
- Change in Functional Status as assessed by 6MWT(Baseline, up to 5 years)
- Heart Failure Readmission Rate(5 years)
研究者
Joseph Lamelas
Chief and Program Director of Cardiothoracic Surgery
University of Miami