Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01385202
First received: June 27, 2011
Last updated: January 20, 2015
Last verified: January 2015
Results First Received: December 17, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Heart Diseases
Arrhythmia
Atrial Fibrillation
Intervention: Device: THERMOCOOL® SMARTTOUCH™ Catheter

  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 June 02, 2011. Twenty-one (21) sites enrolled subjects. Last patient enrolled on December 22, 2011. Last procedure on December 29, 2011.

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
THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter

Participant Flow:   Overall Study
    THERMOCOOL® SMARTTOUCH™ Catheter  
STARTED     172 [1]
Study Catheter Inserted     161  
Undergoing Ablation     160  
COMPLETED     154  
NOT COMPLETED     18  
Lost to Follow-up                 6  
Not Eligible                 11  
Withdrawn                 1  
[1] Per protocol, enrolled subjects were defined as those who signed inform consent form.



  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.
All enrolled subjects, including all who signed inform consent form.

Reporting Groups
  Description
THERMOCOOL® SMARTTOUCH™ Catheter THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter

Baseline Measures
    THERMOCOOL® SMARTTOUCH™ Catheter  
Number of Participants  
[units: participants]
  172  
Age  
[units: Years]
Mean ± Standard Deviation
  58.8  ± 11.0  
Gender  
[units: participants]
 
Female     48  
Male     124  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     165  
More than one race     0  
Unknown or Not Reported     3  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     168  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     172  



  Outcome Measures
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1.  Primary:   The Rate of Subjects Who Were Free From Documented Symptomatic Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atrial Flutter (AFL) Episodes Through 12-month Follow-up   [ Time Frame: 12-months ]

2.  Primary:   Incidence of Early Onset (Within 7 Days of the AF Ablation Procedure) Primary Adverse Events.   [ Time Frame: 7 days of the AF ablation procedure ]

3.  Secondary:   Rate of Acute Success   [ Time Frame: End of procedure ]


  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, Manager, Clinical Operations
Organization: Biosense Webster, Inc.
phone: (800) 729-9010 ext 8611
e-mail: RStagg@its.jnj.com


No publications provided by Biosense Webster, Inc.

Publications automatically indexed to this study:

Responsible Party: Biosense Webster, Inc.
ClinicalTrials.gov Identifier: NCT01385202     History of Changes
Other Study ID Numbers: Smart-AF
Study First Received: June 27, 2011
Results First Received: December 17, 2014
Last Updated: January 20, 2015
Health Authority: United States: Food and Drug Administration