Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation (PAF)
• Interventions: Device: Blazer Open-Irrigated Ablation Catheter (Boston Scientific); Device: FDA Approved Open-Irrigated Ablation Catheter

• Registration Number: NCT01687166
• Lead Sponsor: Boston Scientific Corporation

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-09-13
• Study First Posted: 2012-09-18
• Study Start: 2012-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2018-02-15
• Results First Submitted QC: 2018-06-15
• Results First Posted: 2018-06-18
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-24
• Last Update Posted: 2018-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blazer Open-Irrigated Ablation Catheter	Blazer Open-Irrigated Ablation Catheter (Boston Scientific)	Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system
FDA Approved Open-Irrigated Ablation Catheter	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.

Primary Outcome Measures

Name	Time	Method
Chronic Success Rate	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.
Procedure-related Complication Free Rate	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.

Secondary Outcome Measures

Name	Time	Method
Acute Success	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.

Trial Locations

Locations (38)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Caritas St. Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States

Sequoia Hospital; 🇺🇸 Redwood City, California, United States

Hunstville Hospital; 🇺🇸 Huntsville, Alabama, United States

Georgia Health Sciences University; 🇺🇸 Augusta, Georgia, United States

Union Memorial Hospital; 🇺🇸 Baltimore, Maryland, United States

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States

New York University; 🇺🇸 New York, New York, United States

Mt. Sinai Medical Center; 🇺🇸 New York, New York, United States

Strong Memorial Hospital of the University of Rochester; 🇺🇸 Rochester, New York, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Trinity Mother of Frances Health System; 🇺🇸 Tyler, Texas, United States

University of Texas Health Science Center; 🇺🇸 Houston, Texas, United States

Heart Care Partners; 🇦🇺 Brisbane, Queensland, Australia

Royal Adelaide Hospital; 🇦🇺 Adelaide, South Australia, Australia

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States

CHU of Bordeaux; 🇫🇷 Pessac, Gironde, France

Na Homolce Hospital; 🇨🇿 Prague, Czechia

Charité University Berlin; 🇩🇪 Berlin, Germany

Staedtisches Klinikum Karlsruhe; 🇩🇪 Karlsruhe, Germany

Hospital Clinico Y Provincial; 🇪🇸 Barcelona, Spain

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Clínica Universitaria de Navarra; 🇪🇸 Pamplona, Spain

Golden Jubilee National Hospital; 🇬🇧 Glasgow, United Kingdom

Jersey Shore University Medical Center; 🇺🇸 Neptune, New Jersey, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

St. Vincent's Medical Center; 🇺🇸 Jacksonville, Florida, United States

Centro Hospital de Santa Cruz; 🇵🇹 Carnaxide, Portugal

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of North Carolina Medical Center; 🇺🇸 Chapel Hill, North Carolina, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Baptist Hospital; 🇺🇸 Pensacola, Florida, United States