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

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
Paroxysmal Atrial Fibrillation (PAF)
Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
Device: FDA Approved Open-Irrigated Ablation Catheter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 472
Study Start Date: October 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687166

Contacts
Contact: Bryan Wylie (408) 935-6166 bryan.wylie@bsci.com
Contact: Lynnett Voshage-Stahl 651-582-2994 Lynnett.Voshage-Stahl@bsci.com

  Show 22 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Andrea Natale, M.D. Texas Cardiac Arrhythmia Institute at St. David's Medical Center
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01687166     History of Changes
Other Study ID Numbers: CDM00048665
Study First Received: August 29, 2012
Last Updated: March 30, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Paroxysmal Atrial Fibrillation
Cardiac Arrhythmias
Heart Disease
Cardiovascular Disease
Radiofrequency Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acifluorfen
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014