Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation (ZERO-AF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01687166
First received: August 29, 2012
Last updated: March 30, 2014
Last verified: May 2013

August 29, 2012
March 30, 2014
October 2012
December 2014   (final data collection date for primary outcome measure)
  • Procedure-related complication free rate [ Time Frame: 7-days post-index procedure ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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.

Same as current
Complete list of historical versions of study NCT01687166 on ClinicalTrials.gov Archive Site
Acute Success [ Time Frame: 20 minutes after the last radiofrequency application to isolate the pulmonary vein ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Paroxysmal Atrial Fibrillation (PAF)
  • Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
  • Device: FDA Approved Open-Irrigated Ablation Catheter
  • Experimental: Blazer Open-Irrigated Ablation Catheter
    Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system
    Intervention: 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.
    Intervention: Device: FDA Approved Open-Irrigated Ablation Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
472
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Bryan Wylie (408) 935-6166 bryan.wylie@bsci.com
Contact: Lynnett Voshage-Stahl 651-582-2994 Lynnett.Voshage-Stahl@bsci.com
United States,   Australia,   Portugal,   Sweden
 
NCT01687166
CDM00048665
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Andrea Natale, M.D. Texas Cardiac Arrhythmia Institute at St. David's Medical Center
Boston Scientific Corporation
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP