Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)
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|ClinicalTrials.gov Identifier: NCT01687166|
Recruitment Status : Completed
First Posted : September 18, 2012
Results First Posted : June 18, 2018
Last Update Posted : November 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Paroxysmal Atrial Fibrillation (PAF)||Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific) Device: FDA Approved Open-Irrigated Ablation Catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||398 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
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
- Procedure-related Complication Free Rate [ Time Frame: 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.
- 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: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687166
|Principal Investigator:||Andrea Natale, M.D.||Texas Cardiac Arrhythmia Institute at St. David's Medical Center|