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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Boston Scientific Corporation

Current Primary Outcome:

• 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.

Original Primary Outcome:

• Primary Safety [ Time Frame: 7 days ]
  Procedure-related complication-free rate through 7 days post-procedure.
• Primary Effectiveness [ Time Frame: 30 minutes ]
  Bidirectional block of the cavo-tricuspid isthmus at least 30 minutes following the last RF application in the isthmus.

Current Secondary Outcome:

• 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.

Original Secondary Outcome: Secondary Effectiveness [ Time Frame: 3 months ]

Dates:
Date Received: November 21, 2010
Date Started: January 2011
Date Completion:
Last Updated: April 16, 2014
Last Verified: February 2013