Abstract 11483: Rationale and Design of Randomized Controlled Trial Evaluating an Atrial Appendage Micrograft Transplantation in Conjunction With Coronary Artery Bypass Surgery

Abstract

Introduction: In addition to the revascularization therapies for ischemic heart disease (IHD), such as coronary artery bypass grafting (CABG), tissue-engineered cell therapies can help further improve myocardial repair. First clinical results on autologous right atrial appendage-derived micrograft (AAM) transplantation have demonstrated excellent safety and feasibility profiles and suggested a therapeutic effect on myocardial viability. This randomized clinical trial aims to extend the evaluation of efficacy of AAMs transplantation when combined with CABG surgery. Methods and objectives: This double-blinded randomized controlled AAMS2 trial will assess the benefits, safety, and feasibility of the perioperatively assembled and epicardially transplanted AAMs-patch in conjunction with CABG. The trial recruits a total of 50 patients, half of which are randomized to receive the AAMs-patch (CABG+AAMs) and the other half to undergo a standard CABG. Prior to surgery, cardiac structure and function are assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI), electrocardiogram, and transthoracic echocardiography (TTE). LGE-CMRI, electrocardiogram, and TTE are repeated at 6-month follow-up for structural and functional comparisons to baseline. The primary endpoints focus on the efficacy of the AAMs patch as evaluated by LGE-CMRI and TTE as well as changes in health-related quality of life assessments, 6-minute walk test or N-terminal-pro-BNP levels. The secondary endpoints centre on feasibility and safety. For molecular and especially RNA-level analysis of the response to therapy in blood, RNA-stabilized whole blood and plasma samples are collected. Conclusions: The AAMS2 trial is expected to provide further feasibility and safety data as well as insights for efficacy of epicardial AAMs-patch transplantation when administered during CABG surgery.