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

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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Flutter
• Intervention / Treatment: Device: Blazer® Open-Irrigated Ablation Catheter; Device: Control Catheter

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™).

• Study Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama At Birmingham
  • California
    • Fullerton, California, United States, 92835
      • St. Jude Medical Center
    • Sacramento, California, United States, 95819
      • Regional Cardiology Associates
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Colorado Springs Cardiologist, P.C.
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Hospital Center
  • Florida
    • Hudson, Florida, United States, 34667
      • West Coast Arrhythmia Center
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Memorial Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University Hospital
    • Augusta, Georgia, United States, 30912
      • Georgia Health Sciences University
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Kentucky
    • Lexington, Kentucky, United States, 40503
      • Central Baptist Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02135
      • Caritas St. Elizabeth's Medical Center
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Nebraska Heart Institute
  • New York
    • Rochester, New York, United States, 14642
      • Strong Memorial Hospital of the University of Rochester
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Moses H. Cone Memorial Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia Research
    • Houston, Texas, United States, 77030
      • Hall Garcia Cardiology
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Norfolk General Hospital
  • Washington
    • Seattle, Washington, United States, 98133
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Investigators: Principal Investigator: Tom McElderry, MD, University of Alabama At Birmingham

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 21, 2010
• First Submitted That Met QC Criteria: December 2, 2010
• First Posted (Estimate): December 3, 2010

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: February 15, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Heart Diseases; Arrhythmias, Cardiac; Type 1 Atrial Flutter; Typical Atrial Flutter
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Acifluorfen
• Other Study ID Numbers: BLOCk-CTI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes