Epicardial Delivery of Autologous Atrial Appendage Micrografts During Coronary Artery Bypass Surgery - Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Safety; need for vasoactive medication
研究概览
简要总结
This study aims to evaluate the safety and clinical feasibility of epicardially delivered autologous atrial appendage micrografts in the treatment of heart failure. The micrografts consisting atrial-derived cells and their extracellular matrix, are placed on an infarction scar during CABG surgery.
详细描述
The atrial appendages are a tissue reservoir for cardiomyocyte stem and precursor cells. During coronary artery bypass graft (CABG) surgery part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. This study aims to address the surgical feasibility and patient safety of epicardially delivered atrial appendage micrografts during CABG surgery.
Autologous cardiac cells are harvested from right atrial appendage during CABG of six patients. Micrografts consisting atrial appendage-derived cells (AADCs) and their extracellular matrix (ECM) of the atrial appendage are mechanically processed. The cells are placed on a tissue-engineered sheet with fibrin gel and tissue clue and further delivered epicardially on top of a infarction scar. Parameters including echocardiography reflecting cardiac insufficiency are studied pre- and post-operatively as well as at three and six months of the follow-up. Cardiac functional magnetic resonance imaging is performed preoperatively and at six-months follow-up. 20 patients will be recruited to serve as a control group. They are scheduled for elective CABG and are treated according to the normal hospital protocol, without the ECM sheet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained
- •Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
- •New York Heart Association (NYHA) Class II-IV heart failure symptoms
排除标准
- •Heart failure due to left ventricular outflow tract obstruction
- •History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator
- •Stroke or other disabling condition within 3 months before screening
- •Severe valve disease or scheduled valve surgery
- •Renal dysfunction (GFR <84 ml/min/1.73m)
- •Other disease limiting life expectancy
- •Contraindications for coronary angiogram or MRI
- •Participation in some other clinical trial
结局指标
主要结局
Safety; need for vasoactive medication
时间窗: 6 months
For assessing haemodynamics during the operation and at the intensive care unit
Safety; cardiac index in l/min/m
时间窗: 6 months
For assessing haemodynamics during the operation and at the intensive care unit
Safety; hemoglobin in g/l
时间窗: 6 months
For assessing haemodynamics during the operation and at the intensive care unit
Safety; oxygen saturation in the pulmonary arterial blood (SvO2) in %
时间窗: 6 months
For assessing haemodynamics during the operation and at the intensive care unit
Safety; serum potassium level in mmol/l
时间窗: 6 months
For assessing haemodynamics during the operation and at the intensive care unit
Safety; blood glucose level in mmol/l
时间窗: 6 months
For assessing haemodynamics during the operation and at the intensive care unit
Safety; Left ventricular ejection fraction (EF) in %
时间窗: 6 months
For assessing cardiac function during and after the operation by echocardiogram
Safety; pericardial effusion in mm
时间窗: 6 months
For assessing cardiac function after the operation by echocardiogram
Safety: telemetric monitoring of rhythm
时间窗: 6 months
For assessing cardiac function after the operation
Feasibility: Success in completing the delivery of the cell sheet to the myocardium
时间窗: 6 months
Measured in 0= success, 1= no success
Feasibility: Waiting time in minutes for the cell sheet
时间窗: 6 months
Waiting time in minutes for the finished cell sheet to be placed on the myocardium after doing all the required anastomoses
Feasibility: Waiting time in minutes for the heart
时间窗: 6 months
Waiting time in minutes for the the heart after doing all the anastomoses and before the cell sheet is finished
Feasibility: Closing the right atrial appendage
时间窗: 6 months
Closing the right atrial appendage after removing the standardized tissue piece for preparing the cell sheet. According to the hospital protocol, appendage is closed with purse string suture. 0 = no additional suturing needed, 1 = additional suturing needed.
次要结局
- Left ventricular wall thickness(6 months)
- Change in the amount of myocardial scar tissue(6 months)
- Change in left ventricular ejection fraction(6 months)
- Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels(6 months)
- Days in hospital(1 month)
- New York Heart Association class(6 months)
- Changes in the quality of life.(6 months)
- Local changes in systolic and diastolic function(3 months)
- Change in movement and diastolic function of left ventricular wall(6 months)
研究者
Ari Harjula
Professor, Clinical research
Helsinki University Central Hospital