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