NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (AFTX)
This trial evaluates the safety and effectiveness of catheter ablation for PAF. The investigational catheter being studied is the NAVISTAR® THERMOCOOL® irrigated-tip catheter. At the time of this study, the NAVISTAR® THERMOCOOL® Catheter was FDA-approved for commercial distribution in the U.S. for treating patients with Type I atrial flutter and drug refractory monomorphic sustained ventricular tachycardia post myocardial infarction. The catheter was approved for use in Europe for endocardial ablation for treating cardiac arrhythmias.
Device: Radiofrequency Ablation
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study|
- Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361. [ Time Frame: From study day 91 through day 361 ] [ Designated as safety issue: No ]A subject who exhibited no documented symptomatic PAF episodes was one who 1) had 2 or fewer repeat ablations within 90 days of the initial ablation with investigational catheter; 2) had an addition of antiarrhythmic medication which was previously ineffective for atrial fibrillation and did not exceed the previous historical maximum dosage (24 hour total dose); 3) was on atrioventricular nodal blocking agents such as beta blockers and/or calcium channel blockers and might be maintained at the current dose (ie, did not exceed previous historical maximum dosage (24 hour total dose).
- The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events. [ Time Frame: within 7 days of ablation procedure ] [ Designated as safety issue: Yes ]Catheter-related adverse events include death, myocardial infarction, pulmonary vein stenosis, diaphragmatic paralysis, atrio-esophageal fistula, transient ischemic attack, stroke, cerebrovascular accident, thromboembolism, pericarditis, cardiac tamponade, pericardial effusion, pneumothorax, atrial perforation, vascular access complications, pulmonary edema, hospitalization (initial and prolonged), and heart block.
- Percentage of Subjects Who Achieved Acute Success [ Time Frame: Day 91 - 361 ] [ Designated as safety issue: Yes ]Acute success is defined as the confirmation of entrance block in all targeted pulmonary veins. Acute failure is defined as subjects who have a non-investigational catheter used for ablation of any atrial fibrillation targets or subjects who undergo more than 2 repeat ablation procedures or an ablation procedure beyond day 90.
- 24-hour Holter Data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- TTM Data [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Percentage of Subjects Who Responded to Quality of Life Assessment [ Time Frame: 1 year ] [ Designated as safety issue: No ]SF 36 Symptom Frequency and Severity Checklist
|Study Start Date:||September 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
|Experimental: NaviStar ThermoCool||
Device: Radiofrequency Ablation
The Biosense Webster® NAVISTAR THERMOCOOL Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721149
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||David Wilber, MD||Loyola University Medical Center Chicago|