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

This study has been completed.
Duke Clinical Research Institute
St. Jude Medical
Information provided by:
Mayo Clinic Identifier:
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
Interventions: Drug: Rate Control
Device: Ablation Therapy
Drug: Rate control
Drug: Rhythm Control
Drug: Rhythm control

  Participant Flow

  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
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
Overall Participants 
[units: participants]
 31   29   60 
[units: participants]
<=18 years   0   0   0 
Between 18 and 65 years   20   18   38 
>=65 years   11   11   22 
[units: years]
Mean (Standard Deviation)
 62.1  (9.57)   60.3  (11.46)   61.2  (10.47) 
[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 ]

  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
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.'

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

Results Point of Contact:  
Name/Title: Kristi Monahan
Organization: Mayo Clinic
phone: 507-255-6676


Responsible Party: Douglas L. Packer, MD, Mayo Clinic 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