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



Status:Completed
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/23/2018
Start Date:October 2012
End Date:October 2016

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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.

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.

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
We found this trial at
28
sites
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1 Shircliff Way
Jacksonville, Florida 32204
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Jacksonville, FL
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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1459 Laney-Walker Blvd
Augusta, Georgia 30901
(706) 721-3052
Georgia Health Sciences University Georgia Regents University, home of the Medical College of Georgia, is...
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Augusta, GA
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Austin, TX
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Baltimore, Maryland
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Boston, Massachusetts 02190
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Boston, MA
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Brisbane, Queensland
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Brisbane,
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Chapel Hill, North Carolina
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Chapel Hill, NC
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Columbus, OH
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Houston, TX
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Huntsville, Alabama 35801
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Neptune, New Jersey 07754
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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New York, New York 10029
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Norfolk, VA
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Pensacola, Florida 32501
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Redwood City, California 94062
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Rochester, NY
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Royal Oak, Michigan 48073
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San Francisco, California 94143
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San Francisco, CA
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Tyler, TX
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