Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of 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:

- 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