Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery (AAMS2)
Ischemic Heart Disease, Ischemic Cardiomyopathy, Heart Failure, Systolic
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Ischemic heart failure, Ischemic heart disease, Coronary artery disease, Coronary artery bypass grafting, Atrial appendage micrografts, Tissue-engineering, Ischemic cardiomyopathy, Atrial appendage, Micrografts, Cell Therapy, Epitranscriptomics
Eligibility Criteria
Inclusion Criteria: Informed consent obtained Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography) New York Heart Association (NYHA) Class II-IV heart failure symptoms Exclusion Criteria: 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 <45 ml/min/1.73m2) Other disease limiting life expectancy Contraindications for coronary angiogram or LGE-CMRI Participation in some other clinical trial Screening Failure: After optimization of medications, no visible scar and LVEF ≥ 50% in preoperative LGE-CMRI Preoperative LGE-CMRI has not been performed prior scheduled CABG
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
CABG arm (control)
CABG + AAMs arm (intervention)
In total, 25 patients are recruited to form the CABG group. During CABG surgery, RAA tissue is removed as detailed for the AAMs-patch group. However, the tissue is collected as a sample for later analyses rather than processed to AAMs (Method 4). CABG is performed without epicardial transplantation of AAMs-patch.
In total, 25 patients are recruited to the AAMs-patch group. Here, the AAMs are prepared from the RAA tissue sample by mechanical processing in the operating room during the CABG surgery. The RAA tissue piece is removed during right atrial cannulation, a part of the routine setup of cardiopulmonary bypass. To form an AAMs-patch, the AAMs, embedded in fibrin matrix gel, are placed onto an ECM sheet. This AAMs-patch is kept cold, covered, and sterile until the last stages of CABG surgery. After all the coronary anastomoses are done, the AAMs-patch is epicardially transplanted onto the area identified by preoperative LGE-CMRI to have most suffered from ischemia.