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

Atrial Flutter Clinical Trial

— BLOCk-CTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01253200
• Other study ID #: BLOCk-CTI
• Status: Completed
• Phase: N/A
• First received: November 21, 2010
• Last updated: February 15, 2018
• Start date: January 2011
• Est. completion date: January 2014

Study information

• Verified date: February 2018
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Georgia Health Sciences University	Augusta	Georgia
United States	Texas Cardiac Arrhythmia Research	Austin	Texas
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Caritas St. Elizabeth's Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Colorado Springs Cardiologist, P.C.	Colorado Springs	Colorado
United States	Ohio Health Research Institute	Columbus	Ohio
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. Jude Medical Center	Fullerton	California
United States	Moses H. Cone Memorial Hospital	Greensboro	North Carolina
United States	Hall Garcia Cardiology	Houston	Texas
United States	West Coast Arrhythmia Center	Hudson	Florida
United States	University of Kansas Hospital	Kansas City	Kansas
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	Sentara Norfolk General Hospital	Norfolk	Virginia
United States	Strong Memorial Hospital of the University of Rochester	Rochester	New York
United States	Regional Cardiology Associates	Sacramento	California
United States	Swedish Medical Center	Seattle	Washington
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	ProMedica Toledo Hospital	Toledo	Ohio
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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