clinical evaluation of the blazer open-irrigated ablation catheter for the treatment of paroxysmal atrial fibrillation

Conditions: Paroxysmal Atrial Fibrillation (PAF)

Summary: the purpose of this study is to establish the safety and effectiveness of the blazer open-irrigated radiofrequency ablation catheter for the treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

the zero-af trial is a prospective, multicenter, single blind, 1:1 randomized study. the trial is designed to demonstrate that the safety and effectiveness of the blazer® open-irrigated ablation catheter are non-inferior to the safety and effectiveness of the control catheters, for the treatment drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation. the control catheters are open-irrigated radiofrequency ablation catheters that are approved in the united states for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems.

Eligibility criteria:
inclusion criteria: * history of recurrent symptomatic paf with ≥2 episodes reported within the 365 days prior to enrollment o paf is af episodes that last ≥30 seconds in duration and terminate within 7 days. * at least 1 episode of paf documented by holter monitor, rhythm strip, trans-telephonic monitor (ttm), or 12-lead ecg in the 365 days prior to enrollment * refractory to at least one beta blocker, calcium channel blocker, class i or class iii anti-arrhythmic drug (aad) * age 18 or above, or of legal age to give informed consent specific to state and national law * competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation exclusion criteria: * have any of the following heart conditions within 90 days prior to enrollment: * new york heart association (nyha) class iii or iv * left ventricular ejection fraction (lvef) \<35% * left atrial (la) diameter \>5.5 cm * unstable angina or ongoing myocardial ischemia * transmural myocardial infarction (mi) * congenital structural heart disease that increases the risk of ablation or precludes catheter placement * undergone any left atrial catheter or surgical ablation * have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment * had \>1 af episode lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year * subjects regularly prescribed amiodarone therapy during the 120 days prior to enrollment * contraindication to anticoagulation therapy * creatinine \>2.5mg/dl or creatinine clearance \<30ml/min within 90 days (3 months) prior to enrollment * prosthetic mitral or tricuspid heart valves * confirmed cardiac thrombus within 30 days (1 month) prior to enrollment * implanted pacemaker, icd, or crt leads within 180 days (6 months) prior to enrollment * history of cva, tia or pe within 180 days (6 months) prior to enrollment * left atrial appendage closure device * any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage copd) * enrolled in any concurrent clinical trial without documented pre-approval from bsc * women who are pregnant or plan to become pregnant within the course of their participation in the investigation * life expectancy ≤ 2 years (730 days) per physician opinion

Keywords: paroxysmal atrial fibrillation cardiac arrhythmias heart disease cardiovascular disease radiofrequency ablation