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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: December 21, 2007
Last Update Posted: January 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Duke Clinical Research Institute
St. Jude Medical
Information provided by:
Mayo Clinic
Results First Submitted: July 20, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
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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
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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
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 

  Baseline Characteristics

  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
e-mail: CABANA@mayo.edu


Responsible Party: Douglas L. Packer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00578617     History of Changes
Other Study ID Numbers: 06-003867
First Submitted: December 14, 2007
First Posted: December 21, 2007
Results First Submitted: July 20, 2011
Results First Posted: January 4, 2013
Last Update Posted: January 4, 2013