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NAVISTAR® THERMOCOOL® Catheter Post Approval Registry (AF Registry)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT00964392
First received: August 20, 2009
Last updated: March 16, 2017
Last verified: February 2017
Results First Received: March 10, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Paroxysmal Atrial Fibrillation
Intervention: Procedure: Atrial fibrillation 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
The first subject was enrolled on September 29, 2009. Subject enrollment was completed and closed on October 01, 2013 after reaching a total of 437 enrolled (381 evaluable) subjects. The study is still ongoing. This report covers data up to the data download of June 23, 2015.

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
More-Experienced Physicians (MEP) MEP are defined as those who have performed greater than 50 AF ablation cases per year.
Less-Experienced Physicians (LEP) LEP are defined as those who have performed less than or equal to 50 AF ablations per year.

Participant Flow:   Overall Study
    More-Experienced Physicians (MEP)   Less-Experienced Physicians (LEP)
STARTED   125 [1]   282 [2] 
COMPLETED   72   92 
NOT COMPLETED   53   190 
Withdrawal by Subject                4                6 
Lost to Follow-up                4                10 
Early Termination, non-study arrhythmia                1                6 
Not completed                44                168 
[1] Both safety and efficacy cohort: Total 128 (3 MEP Excluded)
[2] Both safety and efficacy cohort: Total 292 (10 LEP Excluded)



  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.
Enrolled subjects who have been assigned to MEP/LEP groups

Reporting Groups
  Description
More-experienced Physicians Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
Less-experienced Physicians Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
Total Total of all reporting groups

Baseline Measures
   More-experienced Physicians   Less-experienced Physicians   Total 
Overall Participants Analyzed 
[Units: Participants]
 128   292   420 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.0  (9.6)   60.3  (9.5)   60.5  (9.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      44  34.4%      102  34.9%      146  34.8% 
Male      84  65.6%      190  65.1%      274  65.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2   1.6%      7   2.4%      9   2.1% 
Not Hispanic or Latino      126  98.4%      284  97.3%      410  97.6% 
Unknown or Not Reported      0   0.0%      1   0.3%      1   0.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   0.8%      4   1.4%      5   1.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   0.8%      20   6.8%      21   5.0% 
White      125  97.7%      262  89.7%      387  92.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   0.8%      6   2.1%      7   1.7% 
Region of Enrollment 
[Units: Participants]
     
United States   128   292   420 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Subjects Experiencing Primary Adverse Events Within Seven Days of the Ablation Procedure.   [ Time Frame: Seven days post ablation procedure ]

2.  Secondary:   Percentage of Subjects Experienced Serious Adverse Events.   [ Time Frame: First study day to 5 year post-ablation ]


  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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  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: Robert Stagg, Clinical Franchise
Organization: Biosense Webster, Inc.
phone: (800) 729-9010
e-mail: RStagg@its.jnj.com



Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT00964392     History of Changes
Other Study ID Numbers: PMA #P030031/S014
Study First Received: August 20, 2009
Results First Received: March 10, 2016
Last Updated: March 16, 2017