Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure
Heart Failure
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring autologous micrografts, heart failure, coronary artery bypass surgery, cell therapy, atrial appendage, epicardial cell delivery
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained
- Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
- 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 <84 ml/min/1.73m)
- Other disease limiting life expectancy
- Contraindications for coronary angiogram or MRI
- Participation in some other clinical trial
Sites / Locations
- Annu Nummi
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
AACD-Therapy group
Control group
6 patients are recruited to the AADC-therapy group. Autologous atrial appendage derived cells (AADCs) are harvested from the appendage tissue removed during the venal cannulation of bypass. The cells and their extracellular matrix are placed with tissue clue to Cormatrix-sheet and further on top of the myocardium in the area of infarction scar. The procedure is done simultaneously with CABG surgery. The patients will be carefully monitored after the operations and cardiac MRI and echocardiogram will be performed previously to surgery as well as during the follow ups.
20 patients are recruited to form the control group. They are patients scheduled for elective CABG surgery and they meet the same inclusion and exclusion criteria as the therapy group. There patients are followed as the hospital protocol with out any additional imagination or blood tests.