Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter

Not Applicable

Completed

Conditions: Atrial Flutter

Interventions: Device: Blazer® Open-Irrigated Ablation Catheter
Device: Control Catheter

Registration Number: NCT01253200

Lead Sponsor: Boston Scientific Corporation

Brief Summary: The purpose of the BLOCk-CTI study is to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Ablation Catheter for the treatment of sustained or recurrent type 1 atrial flutter. This study will compare outcomes in patients treated with the Blazer® Open-Irrigated Ablation Catheter to outcomes in patients treated with open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter.

Detailed Description: The BLOCk-CTI study is a prospective, multicenter, single blind, 1:1 randomized study. The study 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. In this study, the control catheters are open-irrigated radiofrequency ablation catheters that have 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™).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 302

Inclusion Criteria

At least 1 documented episode of type 1 atrial flutter in the 180 days (6 months) preceding enrollment documented by 12-lead ECG, Holter monitor, rhythm strip, or transtelephonic monitor
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

Any prior right atrial cavo-tricuspid isthmus ablation or any cardiac ablation for non-atrial flutter arrhythmias within 90 days prior to enrollment
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blazer® Open-Irrigated Ablation Catheter	Blazer® Open-Irrigated Ablation Catheter	Patients treated with the Blazer® Open-Irrigated Ablation Catheter
Control 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™),

Primary Outcome Measures

Name	Time	Method
Acute Success Rate	30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus	Acute success is defined as demonstration of bidirectional cavo-tricuspid isthmus block (ie, lack of electrophysiological conduction through the isthmus) 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus with the investigational or control catheter only.
Procedure-related Complication-free Rate	7 days post-procedure	A procedure-related complication is defined as an adverse event that results in death, a life-threatening complication, or a persistent or significant disability/incapacity or required intervention to prevent a permanent impairment of a body function or damage to a body structure. All adverse events related to the investigational or control devices or ablation procedure will be considered procedure-related events.

Secondary Outcome Measures

Name	Time	Method
Chronic Success Rate: All Treated Patients	3 months post-procedure	Chronic success is defined as freedom from recurrence of type 1 atrial flutter at 3-months post-procedure for all treated patients.
Chronic Success Rate: Acute Success Patients	3-months post-procedure	Chronic success is defined as demonstration of acute success and freedom from recurrence of type 1 atrial flutter at 3-months post-procedure. Only randomized patients with acute procedural success will be included in this endpoint.

Trial Locations

Locations (26): Swedish Medical Center
🇺🇸
Seattle, Washington, United States
Brigham and Women's Hospital
🇺🇸
Boston, Massachusetts, United States
Cleveland Clinic Foundation
🇺🇸
Cleveland, Ohio, United States
St. Jude Medical Center
🇺🇸
Fullerton, California, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Regional Cardiology Associates
🇺🇸
Sacramento, California, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Colorado Springs Cardiologist, P.C.
🇺🇸
Colorado Springs, Colorado, 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
Ohio Health Research Institute
🇺🇸
Columbus, Ohio, United States
ProMedica Toledo Hospital
🇺🇸
Toledo, Ohio, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, 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
Caritas St. Elizabeth's Medical Center
🇺🇸
Boston, Massachusetts, 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
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
Henry Ford Hospital
🇺🇸
Detroit, Michigan, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States