PVAC GOLD versus Contact Force Ablation of the Pulmonary Veins for treatment of drug refractory Symptomatic Paroxysmal Atrial Fibrillation: A multicenter randomized clinical trial

OBJECTIVE:As ablation is increasingly in demand for invasive treatment of AF, there is a need for new efficient and safe techniques. Recently, two different strategies have become available: On the one hand, the PVAC GOLD multi-electrode ablation catheter (a ‘single shot’ device that now has gold electrodes for increased RF energy delivery) provides a relatively simple and quick method of pulmonary vein isolation. On the other hand, an alternative multielectrode catheter NMARQ using irrigated RF and 3-D CARTO mapping was designed. It is unknown whether despite their differences, both systems are equally safe and efficient, with similar long-term efficacy. We hypothesize that PVAC GOLD is non-inferior to NMARQ ablation guided by 3-D CARTO mapping. This will be tested by comparing procedural characteristics and long term outcome with regard to safety (cerebral micro-embolism, PV stenosis), and effectiveness regardingThis a curative treatment leading to freedom of AF. HYPOTHESIS:PVAC GOLD is non-inferior to NMARQ ablation with regard to effectiveness and safety in the treatment of AF. STUDY DESIGN:Multicenter Randomized Clinical trial STUDY POPULATION/DATASET:Patients with paroxysmal AF, refractory to anti-arrhythmic drug therapy, which have been accepted for AF ablation according to international standards. INTERVENTION:Invasive catheter ablation for AF by electrical isolation of the pulmonary veins OUTCOME MEASURES:Primary study parameters/outcome of the study:• Effectiveness: Freedom of AF, off Anti-Arrhythmic Drugs, at 1 yr follow-up •Safety: Serious Adverse Events during 30 days post-procedure, including cerebral micro-embolism Secondary study parameters/outcome of the study: •Effectiveness: Freedom from AF on Antiarrhythmic Drugs, Symptom reduction, procedure times •Safety: Serious adverse events during 1 yr follow-up, including PV stenosis SAMPLE SIZE:The sample size calculation is based on the primary chronic efficacy parameter ‘absence of documented symptomatic atrial fibrillation after a blanking period of three (3) months at 12 months. Given this trial is set out to detect non-inferiority of the PVAC GOLD versus the NMARQ catheter; the non-inferiority margin is set at 15%; the efficacy of the GOLD-catheter and NMARQ catheter is estimated at 75%; the power=0.80; the one-sided alpha=0.05. The sample size is calculated to be 104 patients in each group (WinPepi version 11.26). DATA ANALYSIS:For the primary endpoint, ECGs will be performed at baseline and at 3, 6 and 12 months, and when patients are symptomatic. 7-day Holter recordings will be performed at 6 and 12 months. Cerebral MRI scanning will be performed at baseline and at 3 months. Data will be collected by the Antonius Hospital Research and Development Department and analyzed under supervision of the primary investigator. 2-sided Pearson Chi-square Testing and Fisher Exact Testing will be used for analysis of the main outcome and safety end points. COLLABORATION/CONNECTION: to be determined TIME SCHEDULE:Study start Q4 2014, patient inclusion completed Q4 2015, results complete by Q4 2016