NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation (Afib IDE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00116428|
Recruitment Status : Completed
First Posted : June 30, 2005
Results First Posted : March 14, 2013
Last Update Posted : October 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Diseases Arrhythmia Atrial Fibrillation||Device: NAVISTAR® THERMOCOOL® Catheter Drug: Antiarrhythmic drug||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||167 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation|
|Actual Study Start Date :||October 1, 2004|
|Actual Primary Completion Date :||October 1, 2007|
|Actual Study Completion Date :||March 1, 2011|
|Experimental: NAVISTAR® THERMOCOOL® Catheter||
Device: NAVISTAR® THERMOCOOL® Catheter
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.
|Active Comparator: Antiarrhythmic drug||
Drug: Antiarrhythmic drug
Subjects randomized to the antiarrhythmic drug (control) arm will be prescribed to a not previously administered class I or class III antiarrhythmic drug that is currently approved in the U.S. for treating atrial fibrillation.
- The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF) [ Time Frame: The evaluation time frame for the THERMOCOOL catheter subjects is 91-361 days (12 months) post procedure; for Antiarrhythmic Drug Therapy subjects the time frame is 15-285 days (9 months) post procedure. ]Chronic success was defined as freedom of documented symptomatic Atrial Fibrillation episodes based on electrocardiographic data and no changes in antiarrhythmic drugs (AAD) regimen during comparable evaluation periods for the THERMOCOOL and AAD (Control) groups through 12 and 9 months of follow-up, respectively.
- The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events [ Time Frame: Within 7 Days of Ablation Procedure ]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.
- The Percentage of Subjects Who Achieved Acute Success. [ Time Frame: 90 days post study procedure ]Acute success was defined as confirmation of entrance block in all targeted pulmonary veins. The study protocol considered subjects that had more than 2 AF ablation procedures within the 90 day blanking period immediately following their index study procedure or subjects that had additional ablation procedures greater than 80 days following their original study ablation procedure as acute failures.
- Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up. [ Time Frame: During the two years of post procedure ]At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
- Percentage of Subjects Responded to Each of the Four Health Status Categories. [ Time Frame: During the two years of post procedure ]At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116428
|Principal Investigator:||David Wilber, MD||Loyola University|