NAVISTAR® THERMOCOOL® Catheter for the Radiofrequency Ablation of Symptomatic Paroxysmal Atrial Fibrillation- Treatment Use Study (AFTX)

This study has been terminated.
(Enrollment stopped after CDRH Advisory Panel (Nov 20, 2008) recommended NAVISTAR® THERMOCOOL® catheter approval.)
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00721149
First received: July 21, 2008
Last updated: December 3, 2013
Last verified: December 2013
Results First Received: February 8, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Heart Diseases
Arrhythmia
Atrial Fibrillation
Intervention: Device: Radiofrequency Ablation

  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
No text entered.

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 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.

Participant Flow:   Overall Study
    NAVISTAR® THERMOCOOL® Catheter  
STARTED     10 [1]
COMPLETED     9  
NOT COMPLETED     1  
Physician Decision                 1  
[1] Enrollment was stopped after 10 subjects entered the trial.



  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 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.

Baseline Measures
    NAVISTAR® THERMOCOOL® Catheter  
Number of Participants  
[units: participants]
  10  
Age  
[units: years]
Mean ± Standard Deviation
  59.2  ± 13.2  
Gender  
[units: participants]
 
Female     5  
Male     5  
Race (NIH/OMB)  
[units: Participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     10  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     10  
Hypertension Condition  
[units: Participants]
 
With Hypertension     3  
Without Hypertension     7  
Atrial Flutter Condition  
[units: Participants]
 
With Atrial Flutter     2  
Without Atrial Flutter     8  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Who Exhibited no Documented Symptomatic Paroxysmal Atrial Fibrillation (PAF) Episodes From Study Day 91 Through Day 361.   [ Time Frame: From study day 91 through day 361 ]

2.  Primary:   The Percentage of Subjects Who Experienced Incidences of Early Onset (Within 7 Days of Ablation Procedure) Catheter-related Adverse Events.   [ Time Frame: within 7 days of ablation procedure ]

3.  Secondary:   Percentage of Subjects Who Achieved Acute Success   [ Time Frame: Day 91 - 361 ]

4.  Secondary:   24-hour Holter Data   [ Time Frame: 1 year ]

5.  Secondary:   TTM Data   [ Time Frame: 1 year ]

6.  Secondary:   Percentage of Subjects Who Responded to Quality of Life Assessment   [ Time Frame: 1 year ]


  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
Because of early study termination, the study did not reach its targeted enrollment and study data analysis was not fully conducted, thus study results may not be interpretable.


  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.


Results Point of Contact:  
Name/Title: Diana Bordley, Director, Regulatory Affairs
Organization: Biosense Webster, Inc.
phone: 800-729-9010 ext 8604
e-mail: dbordley@its.jnj.com


No publications provided


Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00721149     History of Changes
Other Study ID Numbers: BWI03130TXA
Study First Received: July 21, 2008
Results First Received: February 8, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration