Trial Design

The ENCORE-VT trial was a prospective single-arm phase I/II trial conducted at a single center. Local institutional review board (IRB) approved the study without Investigational Device Exemption (IDE) based on interpretation of the indications for use and risk of linear accelerators and electrocardiographic imaging technology. All participants provided informed consent, and an independent Data and Safety Monitoring Committee (DSMC) reviewed data semi-annually and provided guidance on study continuation. Subsequent to study enrollment, FDA reviewed the protocol and categorized the research as a significant risk study, which requires IDE approval. Although the FDA did not approve the protocol, analysis plan, or data, the investigators, IRB, and FDA worked together to ensure that the appropriate human subject protections were in place.

The trial was designed by CGR and PSC. The first draft of the manuscript was written by CGR and PSC, and decision to publish was made by all authors. Data were analyzed by CGR, PSC, and PPS. The authors vouch for the completeness and accuracy of the data and analyses.