Clinical Evaluation of the Blazer® Open-Irrigated Catheter for Treatment of Type 1 Atrial Flutter (BLOCk-CTI)
|ClinicalTrials.gov Identifier: NCT01253200|
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : February 15, 2018
Last Update Posted : March 19, 2018
|Condition or disease||Intervention/treatment|
|Atrial Flutter||Device: Blazer® Open-Irrigated Ablation Catheter Device: Control Catheter|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Subject was not told by investigator if device used was Investigational or Control. The subject could ask the investigator at end of study at 3 months if they wanted to know which device was used.|
|Official Title:||Clinical Evaluation of the Blazer® Open-Irrigated Radiofrequency Ablation Catheter for the Treatment of Type 1 Atrial Flutter|
|Study Start Date :||January 2011|
|Primary Completion Date :||September 2013|
|Study Completion Date :||January 2014|
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 Name: ThermoCool, NaviStar, EZ Steer, SF, Cool Path, Safire BLU
- Procedure-related Complication-free Rate [ Time Frame: 7 days post-procedure ]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 ]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.
- Chronic Success Rate: All Treated Patients [ Time Frame: 3 months post-procedure ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253200
Show 26 Study Locations
|Principal Investigator:||Tom McElderry, MD||University of Alabama at Birmingham|