ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01253200
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : February 15, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Atrial Flutter
Interventions: Device: Blazer® Open-Irrigated Ablation Catheter
Device: Control Catheter

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from referring physicians for ablation for type 1 atrial flutter

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were excluded if there were no documented episodes of atrial flutter or inclusion criteria were not met. Roll-in subjects were not randomized.

Reporting Groups
  Description
Randomized Blazer® Open-Irrigated Ablation Catheter

Randomized Patients treated with the Blazer® Open-Irrigated Ablation Catheter

Blazer® Open-Irrigated Ablation Catheter: Blazer® Open-Irrigated Ablation Catheter

Randomized Control Catheter

Randomized patients treated with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter

Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter

Roll-in Blazer Open Irrigated Subjects The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
Roll-in Control Catheter The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
Not Randomized to Any Treatment Group Subjects Five subjects were not Randomized to any treatment group and were not Roll-in subjects.

Participant Flow:   Overall Study
    Randomized Blazer® Open-Irrigated Ablation Catheter   Randomized Control Catheter   Roll-in Blazer Open Irrigated Subjects   Roll-in Control Catheter   Not Randomized to Any Treatment Group Subjects
STARTED   125   125   30   17   5 
Procedure   109   111   28   12   0 
10 Day Follow-up   106   111   28   12   0 
3 Month Follow-up   104   106   28   12   0 
COMPLETED   104   106   28   12   0 
NOT COMPLETED   21   19   2   5   5 
Death                1                0                0                0                0 
Lost to Follow-up                1                1                0                0                0 
Withdrawal by Subject                2                0                0                0                0 
Protocol Violation                1                4                0                0                5 
intents                10                10                1                3                0 
Attempts                6                4                1                2                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Randomized Blazer® Open-Irrigated Ablation Catheter Patients randomized to treatment with the Blazer® Open-Irrigated Ablation Catheter
Randomized Control Catheter

Patients randomized to treatment with an open-irrigated radiofrequency ablation catheter that has received FDA market approval for the treatment of type 1 atrial flutter

Control Catheter: Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter

Roll-In Blazer® Open-Irrigated Ablation Catheter The use of the Blazer-Open Irrigated Catheter was required after the second study suspension. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis.
Roll-In Control Catheter The use of the Control Catheter was optional after the second study suspension in a Roll-in subject. Previously enrolled subjects prior to suspension were also classified as Roll-in subjects; not counted in endpoint analysis
Not Randomized to Any Treatment Group Subjects not Randomized to any treatment group and were not Roll-in subjects
Total Total of all reporting groups

Baseline Measures
   Randomized Blazer® Open-Irrigated Ablation Catheter   Randomized Control Catheter   Roll-In Blazer® Open-Irrigated Ablation Catheter   Roll-In Control Catheter   Not Randomized to Any Treatment Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 125   125   30   17   5   302 
Age 
[Units: Years]
Mean (Standard Deviation)
 65  (11)   66  (10)   69  (10)   66  (9)   72  (11)   65.73  (10.54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      23  18.4%      29  23.2%      4  13.3%      4  23.5%      2  40.0%      62  20.5% 
Male      102  81.6%      96  76.8%      26  86.7%      13  76.5%      3  60.0%      240  79.5% 
Region of Enrollment 
[Units: Participants]
           
United States   125   125   30   17   5   302 


  Outcome Measures

1.  Primary:   Procedure-related Complication-free Rate   [ Time Frame: 7 days post-procedure ]

2.  Primary:   Acute Success Rate   [ Time Frame: 30 minutes after the last radiofrequency application in the cavo-tricuspid isthmus ]

3.  Secondary:   Chronic Success Rate: All Treated Patients   [ Time Frame: 3 months post-procedure ]

4.  Secondary:   Chronic Success Rate: Acute Success Patients   [ Time Frame: 3-months post-procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Two interim study suspensions occurred during enrollment that did not impact the integrity of the data and subsequent analyses.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Timothy Meyer; Director of Clinical Trials
Organization: Boston Scientific
phone: 651 581 3425
e-mail: Timothy.meyer@bsci.com



Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01253200     History of Changes
Other Study ID Numbers: BLOCk-CTI
First Submitted: November 21, 2010
First Posted: December 3, 2010
Results First Submitted: March 9, 2017
Results First Posted: February 15, 2018
Last Update Posted: March 19, 2018