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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
No text entered.

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.
No text entered.

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  
Number of Participants  
[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  
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. ]

Measure Type Primary
Measure Title The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Measure Description 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.
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.  
Safety Issue No  

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.
No text entered.

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.

Measured Values
    NAVISTAR® THERMOCOOL® Catheter     Antiarrhythmic Drug  
Number of Participants Analyzed  
[units: participants]
  106     61  
The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)  
[units: Percentage of participants]
  66     16  


Statistical Analysis 1 for The Percentage of Chronic Success of the NAVISTAR THERMOCOOL Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation (PAF)
Groups [1] All groups
Method [2] Log Rank
P Value [3] <0.001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  The study null hypothesis is that the chronic success rates for the THERMOCOOL and AAD groups are equal.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



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 ]

Measure Type Primary
Measure Title The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events
Measure Description 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.
Time Frame Within 7 Days of Ablation Procedure  
Safety Issue Yes  

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.
Analysis population includes those enrolled subjects undergoing a study ablation procedure. A total of 139 underwent the procedure, including 36 AAD (control) group subjects who underwent the procedure after failing the effectiveness endpoint. The remaining 25 AAD (control) subjects didn't have the ablation procedure.

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.

Measured Values
    NAVISTAR® THERMOCOOL® Catheter     Antiarrhythmic Drug  
Number of Participants Analyzed  
[units: participants]
  139     25  
The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events  
[units: Percentage of Participants]
  10.1     0.0  

No statistical analysis provided for The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Serious Catheter-related Adverse Events



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

Measure Type Secondary
Measure Title The Percentage of Subjects Who Achieved Acute Success.
Measure Description 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.
Time Frame 90 days post study procedure  
Safety Issue No  

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.
This analysis population is based on the first study ablation procedure.

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.

Measured Values
    NAVISTAR® THERMOCOOL® Catheter     Antiarrhythmic Drug  
Number of Participants Analyzed  
[units: participants]
  103     36  
The Percentage of Subjects Who Achieved Acute Success.  
[units: Percentage of participants]
  100     94  

No statistical analysis provided for The Percentage of Subjects Who Achieved Acute Success.



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 ]

Measure Type Secondary
Measure Title Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.
Measure Description At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Time Frame During the two years of post procedure  
Safety Issue Yes  

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.
Subjects who completed two years follow up

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 Subjects Undergoing Ablation Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.
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.

Measured Values
    NAVISTAR® THERMOCOOL® Catheter     Antiarrhythmic Drug Subjects Undergoing Ablation     Antiarrhythmic Drug  
Number of Participants Analyzed  
[units: participants]
  92     35     15  
Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.  
[units: Percentage of Participants]
  29.3     28.6     53.3  

No statistical analysis provided for Percentage of Subjects Who Experienced Atrial Fibrillation Recurrence During the Two-year Follow up.



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

Measure Type Secondary
Measure Title Percentage of Subjects Responded to Each of the Four Health Status Categories.
Measure Description At the 2 year follow-up visit, Atrial Fibrillation recurrence was assessed by subject interview without documentation.
Time Frame During the two years of post procedure  
Safety Issue Yes  

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.
Subjects who completed the two-year health survey.

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 Subjects Undergoing Ablation Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.
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.

Measured Values
    NAVISTAR® THERMOCOOL® Catheter     Antiarrhythmic Drug Subjects Undergoing Ablation     Antiarrhythmic Drug  
Number of Participants Analyzed  
[units: participants]
  92     35     15  
Percentage of Subjects Responded to Each of the Four Health Status Categories.  
[units: Percentage of Participants]
     
Two-Year Health Status: Improved     65.2     60.0     53.3  
Two-Year Health Status: Unchanged     29.3     37.1     33.3  
Two-Year Health Status: Worsened     5.4     2.9     6.7  
Two-Year Health Status: Missing     0.0     0.0     6.7  

No statistical analysis provided for Percentage of Subjects Responded to Each of the Four Health Status Categories.




  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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