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.
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™).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
302
Blazer® Open-Irrigated Ablation Catheter
Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
Procedure-related Complication-free Rate
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.
Time frame: 7 days post-procedure
Acute Success Rate
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.
Time frame: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus
Chronic Success Rate: All Treated Patients
Chronic success is defined as freedom from recurrence of type 1 atrial flutter at 3-months post-procedure for all treated patients.
Time frame: 3 months post-procedure
Chronic Success Rate: Acute Success Patients
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.
Time frame: 3-months post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 16 more locations