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

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.

Study Overview

• Status: Completed
• Conditions: Paroxysmal Atrial Fibrillation (PAF)
• Intervention / Treatment: Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific); 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.

• Study Type: Interventional
• Enrollment (Actual): 398
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, QL 4120 QLD
      • Heart Care Partners
  • South Australia
    • Adelaide, South Australia, Australia, SA 5000
      • Royal Adelaide Hospital
• Czechia
  • Prague, Czechia
    • Na Homolce Hospital
• France
  • Gironde
    • Pessac, Gironde, France, 33600
      • CHU of Bordeaux
• Germany
  • Berlin, Germany, 13353
    • Charite University Berlin
  • Karlsruhe, Germany, 76133
    • Staedtisches Klinikum Karlsruhe
• Portugal
  • Carnaxide, Portugal
    • Centro Hospital de Santa Cruz
• Spain
  • Barcelona, Spain, 8036
    • Hospital Clinico Y Provincial
  • Pamplona, Spain, 31008
    • Clinica Universitaria de Navarra
• Sweden
  • Stockholm, Sweden, 171 76
    • Karolinska University Hospital
• United Kingdom
  • Glasgow, United Kingdom, G81 4DY
    • Golden Jubilee National Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Huntsville, Alabama, United States, 35801
      • Hunstville Hospital
  • California
    • Redwood City, California, United States, 94062
      • Sequoia Hospital
    • San Francisco, California, United States, 94143
      • University of California, San Francisco
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center
    • Pensacola, Florida, United States, 32501
      • Baptist Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
    • Augusta, Georgia, United States, 30912
      • Georgia Health Sciences University
  • Maryland
    • Baltimore, Maryland, United States, 21229
      • Union Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • Caritas St. Elizabeth's Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5853
      • University of Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • New Jersey
    • Neptune, New Jersey, United States, 07754
      • Jersey Shore University Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University
    • New York, New York, United States, 10029
      • Mt. Sinai Medical Center
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital of the University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research Foundation
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
    • Tyler, Texas, United States, 75701
      • Trinity Mother of Frances Health System
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure-related Complication Free Rate	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.	12 Months
Chronic Success Rate	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.	Within 12 months of the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Success	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.	Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Andrea Natale, M.D., Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: August 29, 2012
• First Submitted That Met QC Criteria: September 13, 2012
• First Posted (ESTIMATE): September 18, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 21, 2018
• Last Update Submitted That Met QC Criteria: October 24, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Cardiovascular Disease; Heart Disease; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation; Cardiac Arrhythmias
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Acifluorfen
• Other Study ID Numbers: CDM00048665