Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

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