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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00116428
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
Arrhythmia
Atrial Fibrillation
Interventions: Device: NAVISTAR® THERMOCOOL® Catheter
Drug: Antiarrhythmic drug

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This pivotal study was closed to enrollment on October 12, 2007 with a total of 167 subjects enrolled at 19 investigational sites (15 US and 4 outside US).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    NAVISTAR® THERMOCOOL® Catheter   Antiarrhythmic Drug
STARTED   106   61 
COMPLETED   103   56 
NOT COMPLETED   3   5 
Withdrawal by Subject                2                5 
Did not meet inclusion criteria                1                0 



  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
  Description
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 
Overall Participants Analyzed 
[Units: Participants]
 106   61   167 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.5  (9.3)   56.1  (12.8)   55.7  (10.7) 
Gender 
[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 
[1] Ethnicity
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 [1] 
[Units: Number of episodes]
Mean (Standard Deviation)
 62.3  (89.2)   64.9  (98.0)   63.24  (93.0) 
[1] 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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1  

Reporting Groups
  Description
NAVISTAR® THERMOCOOL® Catheter Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. 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 AND didn't undergo a study ablation procedure.

Other Adverse Events
    NAVISTAR® THERMOCOOL® Catheter   Antiarrhythmic Drug
Total, other (not including serious) adverse events     
# participants affected / at risk   23/139 (16.55%)   0/25 (0.00%) 
Blood and lymphatic system disorders     
Hematoma †     
# participants affected / at risk   2/139 (1.44%)   0/25 (0.00%) 
# events   2   0 
Hematoma/Bleeding/groin pain †     
# participants affected / at risk   3/139 (2.16%)   0/25 (0.00%) 
# events   5   0 
Gastrointestinal disorders     
Nausea, Vomiting/Rigors †     
# participants affected / at risk   2/139 (1.44%)   0/25 (0.00%) 
# events   6   0 
General disorders     
Chest Pain †     
# participants affected / at risk   2/139 (1.44%)   0/25 (0.00%) 
# events   2   0 
Back pain †     
# participants affected / at risk   3/139 (2.16%)   0/25 (0.00%) 
# events   3   0 
Injury, poisoning and procedural complications     
Pericardial Effusion †     
# participants affected / at risk   2/139 (1.44%)   0/25 (0.00%) 
# events   2   0 
Nervous system disorders     
Neurologic Side Effects †     
# participants affected / at risk   3/139 (2.16%)   0/25 (0.00%) 
# events   3   0 
Renal and urinary disorders     
Hematuria †     
# participants affected / at risk   3/139 (2.16%)   0/25 (0.00%) 
# events   3   0 
Respiratory, thoracic and mediastinal disorders     
Shortness of Breath †     
# participants affected / at risk   3/139 (2.16%)   0/25 (0.00%) 
# events   3   0 
Events were collected by systematic assessment



  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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