Trials / Completed
CompletedNCT01253200
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 302 (actual)
- Sponsor
- Boston Scientific Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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 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. (Biosense Webster ThermoCool® ablation catheters (NaviStar™, EZ Steer, or SF) or St. Jude Medical ablation catheters (Therapy™ Cool Path™ or Safire BLU™).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2011-01-01
- Primary completion
- 2013-09-01
- Completion
- 2014-01-01
- First posted
- 2010-12-03
- Last updated
- 2018-03-19
- Results posted
- 2018-02-15
Locations
26 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT01253200. Inclusion in this directory is not an endorsement.