Clinical trial NCT01253200: Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
Official title: Clinical Evaluation of the Blazer® Open-Irrigated Radiofrequency Ablation Catheter for the Treatment of Type 1 Atrial Flutter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Flutter
Keywords: Type 1 Atrial Flutter
Typical Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2010-12-03
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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™).

Eligibility criteria: 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

Primary outcomes:
measure: Procedure-related Complication-free Rate
timeFrame: 7 days post-procedure
measure: Acute Success Rate
timeFrame: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus
Secondary outcomes:
measure: Chronic Success Rate: All Treated Patients
timeFrame: 3 months post-procedure
measure: Chronic Success Rate: Acute Success Patients
timeFrame: 3-months post-procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Fullerton
country: United States
facility: St. Jude Medical Center
state: California
city: Sacramento
country: United States
facility: Regional Cardiology Associates
state: California
city: Colorado Springs
country: United States
facility: Colorado Springs Cardiologist, P.C.
state: Colorado
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Hudson
country: United States
facility: West Coast Arrhythmia Center
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Memorial Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Rochester
country: United States
facility: Strong Memorial Hospital of the University of Rochester
state: New York
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Toledo
country: United States
facility: ProMedica Toledo Hospital
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research
state: Texas
city: Houston
country: United States
facility: Hall Garcia Cardiology
state: Texas
city: Norfolk
country: United States
facility: Sentara Norfolk General Hospital
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: University of Alabama at Birmingham
name: Tom McElderry, MD
role: PRINCIPAL_INVESTIGATOR
References: