CARTO® 3 System and Real Time Intracardiac Ultrasound (IUAF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01716663
First received: October 19, 2012
Last updated: November 24, 2014
Last verified: November 2014
Results First Received: November 24, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Atrial Fibrillation
Paroxysmal AF
Intervention: Device: Catheter 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
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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
Experimental: Catheter Ablation

These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.

Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)


Participant Flow:   Overall Study
    Experimental: Catheter Ablation  
STARTED     234 [1]
Safety     230 [2]
COMPLETED     228 [3]
NOT COMPLETED     6  
Withdrawn prior to procedure                 4  
Treated with non-study catheter                 2  
[1] Enrolled = signed informed consent and met eligibility requirements
[2] Enrolled patients who had a study device inserted.
[3] Effectiveness population = enrolled and treated (study device inserted and RF energy applied)



  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

Reporting Groups
  Description
Experimental: Catheter Ablation

These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.

Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)


Baseline Measures
    Experimental: Catheter Ablation  
Number of Participants  
[units: participants]
  234  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     120  
>=65 years     114  
Age  
[units: years]
Mean ± Standard Deviation
  62.1  ± 11.6  
Gender  
[units: participants]
 
Female     94  
Male     140  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     230  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     3  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     223  
More than one race     1  
Unknown or Not Reported     2  



  Outcome Measures
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1.  Primary:   Total Fluoroscopy Time   [ Time Frame: Day 0 ]

2.  Secondary:   Total Procedure Time   [ Time Frame: Day 0 ]

3.  Secondary:   Acute Procedural Success   [ Time Frame: Day 0 ]

4.  Secondary:   Mean Number of Radiofrequency (RF) Applications   [ Time Frame: Day 0 ]

5.  Secondary:   Total Radiofrequency (RF) Time   [ Time Frame: Day 0 ]


  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: Ellen Harris, Project Manager, Clinical Operations
Organization: Biosense Webster
phone: 909-839-7376
e-mail: eharris8@its.jnj.com


No publications provided


Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01716663     History of Changes
Other Study ID Numbers: IUAF
Study First Received: October 19, 2012
Results First Received: November 24, 2014
Last Updated: November 24, 2014
Health Authority: United States: Institutional Review Board