Investigation of the safety and feasibility of AAV1/SERCA2a gene transfer in patients with chronic heart failure and a left ventricular assist device
Design and Objective
A randomised, double blind, placebo-controlled multi-centre pilot study to determine the safety and feasibility of SERCA2a gene transfer in patients with advanced chronic heart failure and LVAD support, the magnitude of viral gene transfer to the human failing myocardium and the influence of circulating neutralising antibodies to AAV1 upon myocardial gene transfer.
Key inclusion criteria
1. Patients that have had a left ventricular assist device (LVAD) implanted for chronic heart failure, where chronic heart failure is defined as at least 6 months 2. Patients are clinically stable in the opinion of the clinical team looking after the patient 3. Written informed consent