Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial (CABANA)

This study has been completed.
Sponsor:
Collaborators:
Duke Clinical Research Institute
St. Jude Medical
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00578617
First received: December 14, 2007
Last updated: December 3, 2012
Last verified: December 2012
Results First Received: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Arrhythmia
Interventions: Drug: Rate Control
Device: Ablation Therapy
Drug: Rate control
Drug: Rhythm Control
Drug: Rhythm control

  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
No text entered.

Reporting Groups
  Description
Drug Therapy Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
Ablation Therapy Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.

Participant Flow:   Overall Study
    Drug Therapy     Ablation Therapy  
STARTED     31     29  
COMPLETED     31     29  
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
Drug Therapy Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
Ablation Therapy Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
Total Total of all reporting groups

Baseline Measures
    Drug Therapy     Ablation Therapy     Total  
Number of Participants  
[units: participants]
  31     29     60  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     18     38  
>=65 years     11     11     22  
Age  
[units: years]
Mean ± Standard Deviation
  62.1  ± 9.57     60.3  ± 11.46     61.2  ± 10.47  
Gender  
[units: participants]
     
Female     5     9     14  
Male     26     20     46  
Region of Enrollment  
[units: participants]
     
United States     31     29     60  



  Outcome Measures

1.  Primary:   Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up   [ Time Frame: 12 months after intervention ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Measure Description Documentation of atrial fibrillation using a cardiac event recorder
Time Frame 12 months after intervention  
Safety Issue No  

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
Drug Therapy Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
Ablation Therapy Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.

Measured Values
    Drug Therapy     Ablation Therapy  
Number of Participants Analyzed  
[units: participants]
  31     29  
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up  
[units: participants]
  20     14  

No statistical analysis provided for Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up




  Serious Adverse Events


  Other Adverse Events
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Time Frame Subjects were followed for adverse events for the 1 year they were on this trial.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   3%  

Reporting Groups
  Description
Drug Therapy Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
Ablation Therapy Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.

Other Adverse Events
    Drug Therapy     Ablation Therapy  
Total, other (not including serious) adverse events      
# participants affected / at risk     8/31     10/29  
Cardiac disorders      
Cardiac Failure † 1    
# participants affected / at risk     0/31 (0.00%)     3/29 (10.34%)  
# events     0     3  
Gastrointestinal disorders      
Nausea † 1    
# participants affected / at risk     3/31 (9.68%)     0/29 (0.00%)  
# events     3     0  
General disorders      
Rash † 1    
# participants affected / at risk     3/31 (9.68%)     0/29 (0.00%)  
# events     3     0  
Metabolism and nutrition disorders      
Fluid Overload † 1    
# participants affected / at risk     0/31 (0.00%)     2/29 (6.90%)  
# events     0     2  
Vascular disorders      
Vascular Injury † 1    
# participants affected / at risk     1/31 (3.23%)     2/29 (6.90%)  
# events     1     2  
Haematoma † 1    
# participants affected / at risk     1/31 (3.23%)     2/29 (6.90%)  
# events     1     2  
Transient Ischaemic Attack † 1    
# participants affected / at risk     0/31 (0.00%)     1/29 (3.45%)  
# events     0     1  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  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
Limited number enrolled. Study was designed to demonstrate feasibility for a pivotal trial, but small enrollment limits the final conclusions that can be drawn from a simple 'time to first atrial fibrillation recurrence.'  


Results Point of Contact:  
Name/Title: Kristi Monahan
Organization: Mayo Clinic
phone: 507-255-6676
e-mail: CABANA@mayo.edu


Publications:

Responsible Party: Douglas L. Packer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00578617     History of Changes
Other Study ID Numbers: 06-003867
Study First Received: December 14, 2007
Results First Received: July 20, 2011
Last Updated: December 3, 2012
Health Authority: United States: Food and Drug Administration