Study:
Clinical Evaluation of the Blazer® Open-Irrigated Radiofrequency Ablation Catheter for the Treatment of Type 1 Atrial Flutter
Rationale:
n/a
Purpose:
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.
Study Status: Recruiting
Recruiting:
Mohamed Kanj, MD 216-445-6008 kanjm@ccf.org
| Condition |
Intervention |
Phase |
|
Atrial Flutter |
Device: Blazer® Open-Irrigated Ablation Catheter Device: Control Catheter |
Phase 3 |
Verified by
Boston Scientific Corporation
February, 2013
Sponsored by: Boston Scientific Corporation
Information provided by: Boston Scientific Corporation
ClinicalTrials.gov identifier: NCT01253200
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Tom McElderry, MD., Principal Investigator