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CONcomitant eValuation of Epicor Left atRial Therapy for AF (CONVERT-AF)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00519194
First received: August 20, 2007
Last updated: May 14, 2014
Last verified: May 2014
Results First Received: March 31, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Device: Epicor LP Cardiac Ablation System
Procedure: Surgical ablation of permanent AF

  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
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Reporting Groups
  Description
Epicor Cardiac Ablation

Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery

Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure


Participant Flow:   Overall Study
    Epicor Cardiac Ablation  
STARTED     112  
COMPLETED     91  
NOT COMPLETED     21  
Withdrawal by Subject                 9  
Death                 9  
Lost to Follow-up                 3  



  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.
Subjects treated

Reporting Groups
  Description
Epicor Cardiac Ablation

Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery

Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery


Baseline Measures
    Epicor Cardiac Ablation  
Number of Participants  
[units: participants]
  112  
Age  
[units: years]
Mean ± Standard Deviation
  72.4  ± 6.9  
Gender  
[units: participants]
 
Female     45  
Male     67  
Region of Enrollment  
[units: participants]
 
United States     112  



  Outcome Measures

1.  Primary:   Freedom From Atrial Fibrillation in the Absence of Any AF Therapies   [ Time Frame: 6 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 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: Sue Walgren, Manager Sr., Clinical Project
Organization: St. Jude Medical
phone: 6517563210
e-mail: swalgren@sjm.com


No publications provided


Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00519194     History of Changes
Other Study ID Numbers: 051.13
Study First Received: August 20, 2007
Results First Received: March 31, 2014
Last Updated: May 14, 2014
Health Authority: United States: Food and Drug Administration