Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)
Paroxysmal Atrial Fibrillation (PAF)
Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
Device: FDA Approved Open-Irrigated Ablation Catheter
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation|
- Procedure-related complication free rate [ Time Frame: 7-days post-index procedure ]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
- Procedure-related complication free rate (continued) [ Time Frame: Within 12 months of the index procedure ]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.
- Chronic success rate [ Time Frame: 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.
- Acute Success [ Time Frame: 20 minutes after the last radiofrequency application to isolate the pulmonary vein ]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.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||November 2016 (Final data collection date for primary outcome measure)|
Experimental: Blazer Open-Irrigated Ablation Catheter
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)|
Active Comparator: 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.
|Device: FDA Approved Open-Irrigated Ablation Catheter|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687166
Show 38 Study Locations
|Principal Investigator:||Andrea Natale, M.D.||Texas Cardiac Arrhythmia Institute at St. David's Medical Center|