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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 February 2015 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01687166
First received: August 29, 2012
Last updated: February 23, 2015
Last verified: February 2015
History of Changes
  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:

U.S. FDA Resources

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: 552
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Micki Weisman 617-218-3849 micki.weisman@bsci.com
Contact: Timothy Meyer, PhD 651-581-3425 Timothy.Meyer@bsci.com

  Show 34 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: February 23, 2015
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on March 03, 2015