1. Clinical Trial for Cardiac Ablation for Type I Atrial Flutter

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3. Blazer II XP Temperature Ablation Catheter Clinical Trial for Cardiac Ablation for Type I Atrial Flutter Status: Approved in 2003 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

4. Design * Prospective, multicenter, single-arm study using objective performance criteria and historical control data from the medical literature Eligible patients had sustained or 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 * Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, 2003. Data can be found at: http://www.fda.gov/ohrms/dockets. Enter product name into search field. http://www.fda.gov/ohrms/dockets

5. Patient Population * 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 three 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 US centers 250 patients enrolled * Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, 2003. Data can be found at: http://www.fda.gov/ohrms/dockets. Enter product name into search field. http://www.fda.gov/ohrms/dockets

6. Clinical Relevance * 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 * Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, 2003. Data can be found at: http://www.fda.gov/ohrms/dockets. Enter product name into search field. http://www.fda.gov/ohrms/dockets

7. Results 1 Summary of Safety and Effectiveness Data. Blazer II XP Cardiac Ablation Catheter, Boston Scientific Corporation, 2003. Data can be found at: http://www.fda.gov/ohrms/dockets. Enter product name into search field http://www.fda.gov/ohrms/dockets 2 Of the 235 acute success patients, 84 patients were not included in the follow-up: 30 patients had not completed their 6-month follow-up at the time the Summary of Safety and Effectiveness Data was reported to the FDA, and 54 were not considered due to: persistent atrial fibrillation (1), death (5), withdrawal or lost to follow-up (6), implanted pacemakers or defibrillators (11), and treatment with Class IA, IC, or III antiarrhythmic drugs (31). 3 Patients who reached 6-month follow-up and were not on class IA, IC, or III antiarrhythmic drugs. 4 Total procedure time defined as the time of first diagnostic catheter insertion until the last diagnostic catheter withdrawal (Source: BSCI/EP Technologies US Atrial Flutter Study Procedure Logistics Form, Rev G – 7/12/2001 – PROCLOG2).

8. Additional References Feld G, Wharton M, Plumb V, Daoud E, Friehling T, Epstein L, for the EPT-1000 XP Cardiac Ablation System Investigators. Radiofrequency catheter ablation of type 1 atrial flutter using large-tip 8- or 10- mm electrode catheters and a high-output radiofrequency energy generator: Results of a multicenter safety and efficacy study. J Am Coll Cardiol 2004; 43:1466-1472.