Using Your Own Heart Tissue to Support Repair During Coronary Artery Bypass Surgery AAMS2 Trial on Atrial Appendage Micrograft Transplants for Ischemic Heart Disease

What this Trial Is About

Ischemic heart disease IHD is a leading cause of death worldwide, characterized by atherosclerotic plaques that reduce oxygen supply to the heart and can lead to heart attacks and heart failure. This trial evaluates a new therapy using the patients own right atrial appendage RAA tissue to support heart repair during coronary artery bypass grafting CABG surgery. The study compares epicardial transplantation of atrial appendage micrografts AAMs to a control group receiving a collagen patch without AAMs, aiming to improve heart regeneration and reduce scarring. During CABG surgery, a piece of the RAA is safely removed and mechanically processed into AAMs, which are embedded in a fibrin gel and placed on a collagen-based patch. This patch is then sutured onto the hearts scarred area identified by preoperative cardiac MRI. The control group undergoes the same surgery but receives only the collagen patch without AAMs. The study enrolls 50 patients randomized equally between the two groups, with treatment and control procedures carried out under double-blinded conditions for patients and evaluating clinicians. Participants undergo assessments before surgery and at 3- and 6-month follow-ups, including blood tests for heart failure biomarkers, transthoracic and transesophageal echocardiography, cardiac MRI scans, symptom evaluations, and a six-minute walking test. Researchers will measure changes in heart scar tissue, heart function, and quality of life, along with monitoring safety events and feasibility of the therapy. The total study duration per participant is about six months, with careful data protection and ongoing safety monitoring throughout the trial.

Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery