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

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. Identifier: NCT00578617
Recruitment Status : Completed
First Posted : December 21, 2007
Results First Posted : January 4, 2013
Last Update Posted : January 4, 2013
Duke Clinical Research Institute
St. Jude Medical
Information provided by:
Mayo Clinic

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

  Baseline Characteristics

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 Analyzed 
[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

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