“… 731 , 732 This ablation system was not approved for clinical use by the FDA due in part to this initial safety signal and the occurrence of 4 strokes (2.9% of patients randomized to ablation) following ablation in the pivotal Tailored Treatment of Permanent Atrial Fibrillation study. 733 , 734 An additional single-arm study to again elucidate the safety of PVAC technology, the Evaluation of Multielectrode Phased RF Technology in Persistent AF (NCT01693120), was subsequently launched but has recently been closed due to lack of enrollment. In summary, there is considerable reason and data to believe that PVAC technology in its redesigned format has achieved at least a similar safety profile as CB or irrigated tip catheter ablation.…”