Heart Failure Clinical Trial
Official title:
Epicardial Delivery of Autologous Atrial Appendage Micrografts During Coronary Artery Bypass Surgery - Safety and Feasibility Study
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.
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.
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