Catheter Ablation -> Atrial Fibrillation & Atrial Flutter: -> Clinical Trials / Outcomes D-PO03 - Poster Session III (ID 48) Poster

D-PO03-129 - Efficacy And Safety Of The Gold Force Multicenter Randomized Clinical Trial: Pvac Gold Vs Irrigated Rf Single Tip Catheter With Contact Force Ablation For Treatment Of Symptomatic Af (ID 1495)


Background: Pulmonary vein isolation (PVI) has evolved as a safe and effective treatment for drug-refractory paroxysmal atrial fibrillation (PAF). PVI can be performed using single-tip (ST) radiofrequency catheters with contact force as Gold standard or with the second-generation multielectrode Phased RF ablation Catheter (PVAC Gold).
Objective: To evaluate the efficacy and safety in patients with symptomatic drug-refractory PAF randomized in the GOLD FORCE trial (PVI using ST RF or multielectrode phased RF).
Methods: The GOLD FORCE trial is a multicenter, non-inferiority randomized controlled study evaluating safety and efficacy of PVI using single tip with contact force or multielectrode PVAC Gold in patients with symptomatic drug-refractory PAF. NCT02463851
Results: A total number of 206 patients underwent randomization (103 assigned to single tip RF ablation, 103 assigned to multielectrode phased RF ablation). Mean age was 61±9; CHA2DS2-VASc 1.0[1.0-2.0], and 73% were male. Pulmonary vein isolation was achieved in 98% of patients and in 99% of PV’s. The mean total procedure time was shorter in the multielectrode phased RF group than in the single tip group, as was the radiofrequency time. The primary efficacy endpoint of documented AF recurrence > 30 seconds is assessed by time-to-first-event analysis after a 90-day blanking period. Secondary endpoints include recurrence of any SVT (atrial tachycardia, atrial flutter), prescription of antiarrhythmic drugs and repeat catheter ablation. The results will be available in March 2020.
Conclusion: In this multicenter randomized clinical trial, ablation with single tip RF ablation and multielectrode phased RF had similar rates of acute PVI . Multielectrode phased RF had significantly shorter procedure and RF times. The 12-month efficacy endpoints will be available in March 2020.