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

Primary Purpose

Paroxysmal Atrial Fibrillation (PAF)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
FDA Approved Open-Irrigated Ablation Catheter
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation (PAF) focused on measuring Paroxysmal Atrial Fibrillation, Cardiac Arrhythmias, Heart Disease, Cardiovascular Disease, Radiofrequency Ablation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Hunstville Hospital
  • Sequoia Hospital
  • University of California, San Francisco
  • Yale University
  • St. Vincent's Medical Center
  • Baptist Hospital
  • Tampa General Hospital
  • Emory University Hospital
  • Georgia Health Sciences University
  • Union Memorial Hospital
  • Caritas St. Elizabeth's Medical Center
  • University of Michigan
  • William Beaumont Hospital
  • Jersey Shore University Medical Center
  • New York University
  • Mt. Sinai Medical Center
  • Strong Memorial Hospital of the University of Rochester
  • University of North Carolina Medical Center
  • Ohio State University Medical Center
  • Hospital of the University of Pennsylvania
  • Medical University of South Carolina
  • Texas Cardiac Arrhythmia Research Foundation
  • University of Texas Health Science Center
  • Trinity Mother of Frances Health System
  • University of Virginia
  • Sentara Norfolk General Hospital
  • Heart Care Partners
  • Royal Adelaide Hospital
  • Na Homolce Hospital
  • CHU of Bordeaux
  • Charité University Berlin
  • Staedtisches Klinikum Karlsruhe
  • Centro Hospital de Santa Cruz
  • Hospital Clinico Y Provincial
  • Clínica Universitaria de Navarra
  • Karolinska University Hospital
  • Golden Jubilee National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blazer Open-Irrigated Ablation Catheter

FDA Approved Open-Irrigated Ablation Catheter

Arm Description

Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system

FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 29, 2012
Last Updated
October 24, 2018
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01687166
Brief Title
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Acronym
ZERO-AF
Official Title
Clinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paroxysmal Atrial Fibrillation (PAF)
Keywords
Paroxysmal Atrial Fibrillation, Cardiac Arrhythmias, Heart Disease, Cardiovascular Disease, Radiofrequency Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
398 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blazer Open-Irrigated Ablation Catheter
Arm Type
Experimental
Arm Description
Blazer Open-Irrigated Ablation Catheter and Ablation Catheter Cable used in conjunction with a compatible electroanatomic mapping system
Arm Title
FDA Approved Open-Irrigated Ablation Catheter
Arm Type
Active Comparator
Arm Description
FDA approved Open-Irrigated Radiofrequency Ablation Catheter system and compatible electroanatomic mapping system for the treatment of paroxysmal atrial fibrillation.
Intervention Type
Device
Intervention Name(s)
Blazer Open-Irrigated Ablation Catheter (Boston Scientific)
Intervention Type
Device
Intervention Name(s)
FDA Approved Open-Irrigated Ablation Catheter
Primary Outcome Measure Information:
Title
Procedure-related Complication Free Rate
Description
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.
Time Frame
12 Months
Title
Chronic Success Rate
Description
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.
Time Frame
Within 12 months of the index procedure
Secondary Outcome Measure Information:
Title
Acute Success
Description
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.
Time Frame
Acute- During Index Procedure, 20 minutes after confirmation of Pulmonary Vein Isolation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale, M.D.
Organizational Affiliation
Texas Cardiac Arrhythmia Institute at St. David's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Hunstville Hospital
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Sequoia Hospital
City
Redwood City
State/Province
California
ZIP/Postal Code
94062
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Baptist Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Georgia Health Sciences University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Union Memorial Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Caritas St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5853
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Strong Memorial Hospital of the University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina Medical Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Texas Cardiac Arrhythmia Research Foundation
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Trinity Mother of Frances Health System
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Heart Care Partners
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
QL 4120 QLD
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
SA 5000
Country
Australia
Facility Name
Na Homolce Hospital
City
Prague
Country
Czechia
Facility Name
CHU of Bordeaux
City
Pessac
State/Province
Gironde
ZIP/Postal Code
33600
Country
France
Facility Name
Charité University Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Staedtisches Klinikum Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Centro Hospital de Santa Cruz
City
Carnaxide
Country
Portugal
Facility Name
Hospital Clinico Y Provincial
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Clínica Universitaria de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Golden Jubilee National Hospital
City
Glasgow
ZIP/Postal Code
G81 4DY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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