The ASCEND-VT pilot study will randomize 40 patients with ischemic cardiomyopathy to pulsed field ablation versus radiofrequency ablation to test non-inferiority in ablation time to eliminate LAVAs.
RCT (n=40)
1:1
No
Does focal pulsed field ablation reduce ablation time to eliminate LAVAs compared to radiofrequency ablation in patients with ischemic cardiomyopathy undergoing VT ablation?
The ASCEND-VT pilot study is designed to test the non-inferiority of focal pulsed field ablation compared to radiofrequency ablation for eliminating late abnormal ventricular activities in patients with ischemic cardiomyopathy.
BackgroundVentricular tachycardia (VT) ablation in patients with ischemic cardiomyopathy (ICM) continues to be a challenging procedure with variable outcomes.Most current ablations are done using radiofrequency ablation (RFA).The new pulsed field ablation (PFA) technology may be able to achieve similar or superior procedural outcomes but potentially over shorter periods of time with less intravascular fluid infusion -but this possibility has never been tested. ObjectivesTo compare the procedural efficacy and safety of VT ablation in ICM patients using focal PFA vs RFA catheters. MethodsThis ASCEND-VT pilot study is a single center trial randomizing patients to RFA vs PFA VT ablation in a 1:1 fashion.The new focal PFA catheter will be used under an investigational device exemption granted by the U.S. Food and Drug Administration.Patients with mechanical valves will be excluded.The primary ablation target will be homogenization of endocardial late abnormal ventricular activity (LAVA).Patients will be followed for 6 months after the procedure. ResultsForty individuals will be randomized.The primary efficacy metric will be the ablation time needed to eliminate LAVAs in each patient.Additional efficacy and safety endpoints will be interrogated after the procedure and during outpatient follow-up. ConclusionJ o u r n a l P r e -p r o o f arms.This will be tested for non-inferiority. Additional efficacy and safety metrics will be assessed after the ablation and over the course of a 6-month follow-up period.
Sroubek et al. (Wed,) conducted a rct in Ventricular tachycardia in ischemic cardiomyopathy (n=40). Pulsed field ablation (PFA) vs. Radiofrequency ablation (RFA) was evaluated on Ablation time needed to eliminate endocardial late abnormal ventricular activity (LAVA). The ASCEND-VT pilot study will randomize 40 patients with ischemic cardiomyopathy to pulsed field ablation versus radiofrequency ablation to test non-inferiority in ablation time to eliminate LAVAs.