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TOCCASTAR - TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01278953
First received: January 17, 2011
Last updated: February 5, 2016
Last verified: February 2016
Results First Received: January 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Paroxysmal Atrial Fibrillation
Intervention: Device: Catheter ablation for the treatment of paroxysmal atrial fibrillation

  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
300 subjects consented to study participation, 5 subjects did not have the study device introduced. Therefore 295 subjects contributed to study endpoints.

Reporting Groups
  Description
TactiCath

Ablation performed using the TactiCath contact force sensing catheter

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Control

Ablation performed using a catheter with no contact force sensing capability

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.


Participant Flow:   Overall Study
    TactiCath     Control  
STARTED     155     145  
COMPLETED     146     134  
NOT COMPLETED     9     11  



  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
TactiCath

Ablation performed using the TactiCath contact force sensing catheter

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Control

Ablation performed using a catheter with no contact force sensing capability

Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation.

Total Total of all reporting groups

Baseline Measures
    TactiCath     Control     Total  
Number of Participants  
[units: participants]
  155     145     300  
Age  
[units: years]
Mean (Standard Deviation)
  59.6  (9.32)     61  (10.84)     60.3  (10.09)  
Gender  
[units: participants]
     
Female     55     54     109  
Male     100     91     191  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     1     0     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     148     141     289  
More than one race     2     2     4  
Unknown or Not Reported     3     2     5  
Region of Enrollment  
[units: participants]
     
United States     96     87     183  
Europe     59     58     117  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter   [ Time Frame: 12 months ]

2.  Primary:   Incidence of Device-related Early-onset Primary Serious Adverse Events   [ Time Frame: 12 months ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Nicole Glowacki
Organization: St Jude Medical
phone: 651-756-2000
e-mail: nglowacki@sjm.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01278953     History of Changes
Other Study ID Numbers: VP-002 527
Study First Received: January 17, 2011
Results First Received: January 7, 2016
Last Updated: February 5, 2016
Health Authority: United States: Food and Drug Administration