NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation (Afib IDE)

This study has been completed.
Information provided by (Responsible Party):
Biosense Webster, Inc. Identifier:
First received: June 29, 2005
Last updated: December 3, 2013
Last verified: December 2013
Results First Received: February 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Diseases
Atrial Fibrillation
Interventions: Device: NAVISTAR® THERMOCOOL® Catheter
Drug: Antiarrhythmic drug

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
NAVISTAR® THERMOCOOL® Catheter Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. 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.
Antiarrhythmic Drug The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
Total Total of all reporting groups

Baseline Measures
    NAVISTAR® THERMOCOOL® Catheter     Antiarrhythmic Drug     Total  
Number of Participants  
[units: participants]
  106     61     167  
[units: years]
Mean (Standard Deviation)
  55.5  (9.3)     56.1  (12.8)     55.7  (10.7)  
[units: participants]
Female     33     23     56  
Male     73     38     111  
Race/Ethnicity, Customized [1]
[units: Participants]
Hispanic     1     0     1  
Native American     1     0     1  
White     103     61     164  
Arab ethnicity     1     0     1  
Region of Enrollment  
[units: participants]
Brazil     7     5     12  
Canada     5     3     8  
Czech Republic     17     10     27  
Italy     31     19     50  
United States     46     24     70  
Number of documented symptomatic Atrial Fibrillation episodes [2]
[units: Number of episodes]
Mean (Standard Deviation)
  62.3  (89.2)     64.9  (98.0)     63.24  (93.0)  
[1] Ethnicity
[2] Number of symptomatic Atrial Fibrillation episodes during the last six months prior to study enrollment.

  Outcome Measures
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1.  Primary:   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. ]

2.  Primary:   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 ]

3.  Secondary:   The Percentage of Subjects Who Achieved Acute Success.   [ Time Frame: 90 days post study procedure ]

4.  Secondary:   Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.   [ Time Frame: During the two years of post procedure ]

5.  Secondary:   Percentage of Subjects Responded to Each of the Four Health Status Categories.   [ Time Frame: During the two years of post procedure ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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