Guided Radiofrequency Ablation Using the CARTO® 3 and NavX™ Systems for the Treatment of Paroxysmal Atrial Fibrillation (CO1)

This study has been terminated.
(Enrollment challenges)
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01036724
First received: December 17, 2009
Last updated: July 17, 2014
Last verified: July 2014
Results First Received: June 18, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Paroxysmal Atrial Fibrillation
Intervention: Device: Cardiac Mapping

  Participant Flow
  Hide Participant Flow

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
Carto 3 Those subjects whose cases use the CARTO 3 EP Navigation System.
NAVX Those subjects whose cases use the NAVX(TM) EP Navigational System.

Participant Flow:   Overall Study
    Carto 3     NAVX  
STARTED     52     55  
COMPLETED     46     47  
NOT COMPLETED     6     8  
Adverse Event                 1                 2  
Lack of Efficacy                 1                 1  
Protocol Violation                 4                 5  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Carto 3 Those subjects whose cases use the CARTO 3 EP Navigation System.
NAVX Those subjects whose cases use the NAVX(TM) EP Navigational System.
Total Total of all reporting groups

Baseline Measures
    Carto 3     NAVX     Total  
Number of Participants  
[units: participants]
  46     47     93  
Age  
[units: years]
Median ( Full Range )
  58  
  ( 22 to 74 )  
  57  
  ( 36 to 79 )  
  58  
  ( 22 to 79 )  
Gender  
[units: participants]
     
Female     14     7     21  
Male     32     40     72  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Fluoroscopy Time   [ Time Frame: Throughout the Total Duration of the Procedure ]

2.  Secondary:   Total Procedure Time   [ Time Frame: Total Duration of the Procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
The study was terminated early, with 107 enrolled and 93 evaluable subjects, due to difficulty enrolling despite prolonged extension of the enrollment period. The original design called for 176 enrolled and 122 evaluable patients.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Dr. Tina Hunter, Consulting Statistician to Biosense Webster
Organization: CTI Clinical Trials and Consulting
phone: 513-619-5541
e-mail: tinah@s2stats.com


No publications provided


Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01036724     History of Changes
Other Study ID Numbers: BWICO1
Study First Received: December 17, 2009
Results First Received: June 18, 2014
Last Updated: July 17, 2014
Health Authority: Canada: Health Canada