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. ]

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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Melissa Schultz, Project Manager, Regulatory Affairs
Organization: Biosense Webster
phone: 800-729-9010 ext 8787
e-mail: mschult1@its.jnj.com


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00116428     History of Changes
Other Study ID Numbers: BWI03130
Study First Received: June 29, 2005
Results First Received: February 11, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration