Organization and ethical concerns
ADVERSE EVENTS, SECONDARY
This is a single‐center, investigator‐initiated study. The study protocol has been approved by the local ethics committee. All patients will provide written informed consent before study participation. All investigators will adhere to Good Clinical Practice and to the ethical principles of the Declaration of Helsinki.An independent Data Safety Monitoring Board (DSMB) consisting of an interventional cardiologist, anesthesiologist and statistician has been established for this study to oversee safety. A blinded interim analysis will be performed after 24 patients have been included and additional interim analysis will be performed when deemed necessary by the DSMB. The DSMB will have access to the unblinded study data (including patient characteristics, invasive procedure details, primary and secondary efficacy endpoints, safety endpoints and relevant serious adverse events) and can give the following recommendations: (i) proceed with the trial according to protocol, (ii) modify the study protocol or study procedures (including, but not limited to, changes in inclusion/exclusion criteria, frequency of safety monitoring, alterations in study procedures and follow‐up period for the purposes of safety), and (iii) terminate inclusion of new patients into the trial.