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

November 21, 2010
April 16, 2014
January 2011
September 2013   (final data collection date for primary outcome measure)
  • 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.
  • Primary Safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Procedure-related complication-free rate through 7 days post-procedure.
  • Primary Effectiveness [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
    Bidirectional block of the cavo-tricuspid isthmus at least 30 minutes following the last RF application in the isthmus.
Complete list of historical versions of study NCT01253200 on ClinicalTrials.gov Archive Site
  • 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.
Secondary Effectiveness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Freedom from recurrence of type 1 atrial flutter at 3-months post-procedure.
Not Provided
Not Provided
 
Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Atrial Flutter
  • Device: Blazer® Open-Irrigated Ablation Catheter
    Blazer® Open-Irrigated Ablation Catheter
  • Device: Control Catheter
    Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
  • Experimental: Blazer® Open-Irrigated Ablation Catheter
    Patients treated with the Blazer® Open-Irrigated Ablation Catheter
    Intervention: Device: 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
    Intervention: Device: Control Catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
302
January 2014
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253200
BLOCk-CTI
No
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
Principal Investigator: Tom McElderry, MD University of Alabama at Birmingham
Boston Scientific Corporation
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP