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

Not Applicable

Completed

Conditions: Paroxysmal Atrial Fibrillation (PAF)

Interventions: Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
Device: FDA Approved Open-Irrigated Ablation Catheter

Registration Number: NCT01687166

Lead Sponsor: Boston Scientific Corporation

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 398

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blazer Open-Irrigated Ablation Catheter	Blazer Open-Irrigated Ablation Catheter (Boston Scientific)	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system
FDA Approved Open-Irrigated Ablation Catheter	FDA Approved Open-Irrigated Ablation Catheter	FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

Primary Outcome Measures

Name	Time	Method
Chronic Success Rate	Within 12 months of the index procedure	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.
Procedure-related Complication Free Rate	12 Months	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.

Secondary Outcome Measures

Name	Time	Method
Acute Success	Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation	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.

Trial Locations

Locations (38): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Hunstville Hospital
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Huntsville, Alabama, United States
Sequoia Hospital
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Redwood City, California, United States
University of California, San Francisco
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San Francisco, California, United States
Yale University
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New Haven, Connecticut, United States
St. Vincent's Medical Center
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Jacksonville, Florida, United States
Baptist Hospital
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Pensacola, Florida, United States
Tampa General Hospital
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Tampa, Florida, United States
Emory University Hospital
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Atlanta, Georgia, United States
Georgia Health Sciences University
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Augusta, Georgia, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States