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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Paroxysmal Atrial Fibrillation (PAF)

Intervention / Treatment
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* Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
* Device: FDA Approved Open-Irrigated Ablation Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blazer Open-Irrigated Ablation Catheter<br>Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system | Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)<br> <br> |
| Active Comparator: FDA Approved Open-Irrigated Ablation Catheter<br>FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation. | Device: FDA Approved Open-Irrigated Ablation Catheter<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure-related Complication Free Rate | The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group serious adverse event rate is non-inferior to that of the control group. The safety of the Blazer OI catheter will be evaluated by demonstrating that the investigational group rate of significant pulmonary vein stenosis (≥70% reduction in diameter from baseline) and atrio-esophageal fistulas is non-inferior to that of the control group. | 12 Months | 
| Chronic Success Rate | The primary effectiveness of the Blazer OI catheter will be evaluated by demonstrating that the proportion of subjects free from failure* in the investigational group is non-inferior to those in the control group. *failure is defined as a randomized subject being an acute procedural failure, having more than one repeat procedure during the 90 day blanking period or having a documented symptomatic atrial fibrillation, atrial tachycardia, atrial fibrillation between 91 days and 12 months post-procedure. | Within 12 months of the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Success | Demonstration that the investigational group acute procedural success rate is non-inferior to that of the control group. Acute procedural success is defined as a subject that successfully had all clinically relevant veins electrically isolated, by demonstration of entrance block at a minimum and no evidence of exit conduction with the randomized investigational or control catheter only. | Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Paroxysmal Atrial Fibrillation, Cardiac Arrhythmias, Heart Disease, Cardiovascular Disease, Radiofrequency Ablation