Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
NCT ID: NCT01253200
Last Updated: 2018-03-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
302 participants
INTERVENTIONAL
2011-01-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Blazer® Open-Irrigated Ablation Catheter
Patients treated with the Blazer® Open-Irrigated Ablation Catheter
Blazer® Open-Irrigated Ablation Catheter
Blazer® Open-Irrigated Ablation Catheter
Control Catheter
Patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter( Biosense Webster ThermoCool® ablation catheters (NaviStar™, EZ Steer, or SF) or St. Jude Medical ablation catheters (Therapy™ Cool Path™ or Safire BLU™),
Control Catheter
Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
Interventions
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Blazer® Open-Irrigated Ablation Catheter
Blazer® Open-Irrigated Ablation Catheter
Control Catheter
Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients are clinically indicated for catheter ablation
* Patients receiving oral anti-arrhythmic drug therapy (class I or class III) for a tachyarrhythmia other than type 1 atrial flutter must be controlled on the anti-arrhythmic drug for a minimum of 30 days prior to enrollment. If type 1 atrial flutter was documented prior to the development of other tachyarrhythmias, this 30-day period is not required.
* Age 18 or above, or of legal age to give informed consent specific to state and national law
* Patients are 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
* Cardiac surgery within 90 days prior to enrollment
* Myocardial infarction within 60 days prior to enrollment
* Current unstable angina
* Patients who cannot have anti-arrhythmic drugs (class I and class III) prescribed for the treatment of type 1 atrial flutter stopped on the day of the procedure
* Patients regularly prescribed amiodarone within the 120 days (4 months) prior to enrollment
* Documented atrial or ventricular tumors, clots, thrombus, or have a known clotting disorder within 90 days prior to enrollment
* Implantation of permanent leads of an implantable device in or through the right atrium within 90 days prior to enrollment
* Direct remedial cause of atrial flutter (e.g. thyroid disease, pericarditis, pulmonary embolic disease)
* Atypical or scar-based flutter
* Patients with New York Heart Association Class III at the time of enrollment or New York Heart Association Class IV heart failure within 90 days prior to enrollment
* Patients with an ejection fraction less than 30% within 90 days prior to enrollment
* Clinically significant structural heart disease (including tricuspid valve regurgitation, tricuspid valve stenosis, tricuspid valve replacement, Ebstein's anomaly, or other congenital heart disease) that would preclude catheter introduction and placement, as determined by the Investigator
* Any cerebral ischemic event (including transient ischemic attacks) within 180 days prior to enrollment
* Contraindication to anticoagulation therapy based upon published guidelines
* Creatinine greater than 2.5 mg/dl or creatinine clearance less than 30 mL/min within 90 days prior to enrollment
* Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness)
* Enrolled in any concurrent study without BSC written approval
* Women who are pregnant or plan to become pregnant within the course of their participation in the investigation
* Life expectancy less than or equal to 2 years (730 days) per physician opinion
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Tom McElderry, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
St. Jude Medical Center
Fullerton, California, United States
Regional Cardiology Associates
Sacramento, California, United States
Colorado Springs Cardiologist, P.C.
Colorado Springs, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
West Coast Arrhythmia Center
Hudson, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Georgia Health Sciences University
Augusta, Georgia, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Central Baptist Hospital
Lexington, Kentucky, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Nebraska Heart Institute
Lincoln, Nebraska, United States
Strong Memorial Hospital of the University of Rochester
Rochester, New York, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research
Austin, Texas, United States
Hall Garcia Cardiology
Houston, Texas, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Other Identifiers
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BLOCk-CTI
Identifier Type: -
Identifier Source: org_study_id
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