During the staged hybrid procedure, the minimally invasive surgical ablation is performed first and catheter optimization is scheduled separately. In addition, the investigators discussed recruiting new sites for a pivotal trial and a review of the initial clinical results.
The scheduling and logistics aspects of performing the hybrid procedure in the same session can present certain challenges. Although three of the five investigational sites were advocating to continue with the same-session procedure, all the investigators agreed that during the learning curve period, having the surgeon perform the minimally invasive procedure in their operating room and having the electrophysiologist perform their catheter optimization procedure in their EP lab may reproduce and lessen complications and alleviate the logistical challenges of integrating this procedure into certain new investigational sites.
In terms of safety, a report of the adverse events was presented to the investigators and the results were considered acceptable by the investigators given that the patients are subject to the cumulative risk of a minimally invasive surgical procedure as well as a catheter based procedure and that the treatment options for the study population are limited.
A total of seven primary adverse events, including one stroke occurring on postoperative day 27, resulting in death on day 30, were reported to the investigators and discussed interactively throughout the meeting. No adverse events were attributed to the investigational device. Importantly, the investigators recommended that we continue to discussions with FDA concerning the need for including a severity index into the clinical protocol in order to more accurately assess the risk-benefit profile of this investigational procedure and system.In the interim, it was recommended that adverse events should be further graded as mild, moderate, or severe. In addition, the independent physician adjudicator presented a report to the DSMB and characterized all of the events as mild or moderate, except for the aforementioned stroke and subsequent death.