A Study of the Effectiveness of Anti-Arrhythmic Medications After Atrial Fibrillation Ablation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00408200
First received: December 1, 2006
Last updated: January 31, 2013
Last verified: June 2012
Results First Received: September 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Atrial Fibrillation
Interventions: Drug: propafenone; flecainide; sotalol; dofetilide
Device: Radiofrequency 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
Recruitment period: 12/06 to 3/08.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following consent/enrollment, subject and investigator were blinded to treatment arm until after the ablation procedure. Subjects were later withdrawn if the procedure was not completed, or if a disqualifying medication history or other protocol exclusion was identified.

Reporting Groups
  Description
AAD:NO

Subjects do not receive membrane-active anti-arrhythmic medications after ablation.

Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.

AAD:YES

Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.

Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.

propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF


Participant Flow:   Overall Study
    AAD:NO     AAD:YES  
STARTED     57     53  
COMPLETED     57     53  
NOT COMPLETED     0     0  



  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
AAD:NO

Subjects do not receive membrane-active anti-arrhythmic medications after ablation.

Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.

AAD:YES

Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.

Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.

propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF

Total Total of all reporting groups

Baseline Measures
    AAD:NO     AAD:YES     Total  
Number of Participants  
[units: participants]
  57     53     110  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     57     53     110  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     16     16     32  
Male     41     37     78  
Region of Enrollment  
[units: participants]
     
United States     57     53     110  



  Outcome Measures
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1.  Primary:   Composite Endpoint: Atrial Arrhythmias Lasting >24 Hrs or Requiring Antiarrhythmic Drug Therapy; Need for Cardioversion/Repeat Ablation During the Study Period; Adverse Outcome/Intolerance of Antiarrhythmic Agent Requiring Cessation or Change of Drug   [ Time Frame: 6 weeks ]

2.  Secondary:   Freedom From Atrial Arrhythmia at 6 Months Post Procedure.   [ Time Frame: 6 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
No text entered.  


Results Point of Contact:  
Name/Title: Anthony Killian
Organization: University of Pennsylvania
phone: 215-615-5299
e-mail: tony.killian@uphs.upenn.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00408200     History of Changes
Other Study ID Numbers: 805346HUP
Study First Received: December 1, 2006
Results First Received: September 12, 2012
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board