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

Study Overview
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Brief Summary
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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
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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™).

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

Conditions
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Atrial Flutter

Intervention / Treatment
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* Device: Blazer® Open-Irrigated Ablation Catheter
* Device: Control Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blazer® Open-Irrigated Ablation Catheter<br>Patients treated with the Blazer® Open-Irrigated Ablation Catheter | Device: Blazer® Open-Irrigated Ablation Catheter<br>* Blazer® Open-Irrigated Ablation Catheter<br>|
| Active Comparator: Control Catheter<br>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™), | Device: Control Catheter<br>* Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter<br>* Other names: ThermoCool, NaviStar, EZ Steer, SF, Cool Path, Safire BLU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3-months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Atrial Flutter, Typical Atrial Flutter, Arrhythmias, Cardiac, Heart Diseases, Cardiovascular Diseases