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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01253200
First received: November 21, 2010
Last updated: April 16, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Atrial Flutter
Device: Blazer® Open-Irrigated Ablation Catheter
Device: Control Catheter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Blazer® Open-Irrigated Radiofrequency Ablation Catheter for the Treatment of Type 1 Atrial Flutter

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Procedure-related complication-free rate [ Time Frame: 7 days post-procedure ] [ Designated as safety issue: Yes ]
    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.

  • Acute success rate [ Time Frame: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Chronic success rate: all treated patients [ Time Frame: 3 months post-procedure ] [ Designated as safety issue: No ]
    Chronic success is defined as freedom from recurrence of type 1 atrial flutter at 3-months post-procedure for all treated patients.

  • Chronic success rate: acute success patients [ Time Frame: 3-months post-procedure ] [ Designated as safety issue: No ]
    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.


Enrollment: 302
Study Start Date: January 2011
Study Completion Date: January 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: Control Catheter
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253200

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

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01253200     History of Changes
Other Study ID Numbers: BLOCk-CTI
Study First Received: November 21, 2010
Last Updated: April 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Scientific Corporation:
Type 1 Atrial Flutter
Typical Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Acifluorfen
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014