Blazer™ II XP
Radiofrequency Catheter Ablation of Type 1 Atrial Flutter Using Large-Tip 8 or 10 mm Electrode Catheters and a High-Output Radiofrequency Energy Generator
Status: Completed: 2003
Clinical Study for Cardiac Ablation for Type I Atrial Flutter Using Large Tipped Catheters - Blazer II XP Catheters with the EPT-1000XP High-powered Generator.
First clinical trial to prove the safety and effectiveness of 8 and 10 mm tip ablation catheters used with a 100 W cardiac ablation system for the treatment of type 1 atrial flutter.
- Prospective, multicenter, single-arm study using objective performance criteria and historical control data from the medical literature.
- Eligible patients had sustainedor recurrent Type 1 atrial flutter.
- Procedural success was defined as complete bidirectional isthmus block with noninducible Type 1 atrial flutter with only the use of the Blazer II XP Catheter and EPT-1000XP™ Cardiac Ablation System and accessories.
- Chronic success was demonstration of acute procedural success and continued absence of targeted type 1 atrial flutter for 6 months after the ablation procedure.
- Procedural safety was the absence of serious complications associated with the use of the Blazer II XP Catheter and EPT-1000XP System within 7 days of the ablation procedure.
- Clinical follow-up was performed at 1, 3, and 6 months, and at 1 and 2 years following the procedure.
Eligible study participants included both male and female patients over 18 years of age that had experienced ≥2 documented episodes of atrial flutter (by ECG, Holter, rhythm strip or ICD) within 6 months prior to enrollment or who had ≥1 documented episodes of atrial flutter (ECG, Holter, rhythm strip, or ICD) during the 6 months preceding study enrollment. Some of the exclusion criteria were:
- Patients with a direct remedial cause of atrial flutter (e.g., thyroid disease, pericarditis, pulmonary embolic disease)
- Patients with any prior isthmus cardiac ablation for Type 1 AFL
- Patients in treatment for non-atrial flutter (Type 1) arrhythmias with anti-arrhythmic drugs (class IA, IC, or III) within 3 months preceding study entry
- Patients who received cardiac ablation or cardioversion for other types of non-atrial flutter (Type 1) arrhythmias within 3 months preceding study entry
23 U.S. centers
250 patients enrolled
- To evaluate the safety and effectiveness of large-tip catheter ablation in patients with Type 1 atrial flutter
- The primary endpoints were acute procedural success, chronic (6 month) success, and complication rate per Bayesian analysis
- First trial to demonstrate the safety and effectiveness of 8 and 10 mm tip catheters used with a 100 W system for the treatment of Type 1 atrial flutter