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

History of Changes

Results First Received: July 20, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (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
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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

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.
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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
Overall Participants Analyzed [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 ]

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Serious Adverse Events

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Other Adverse Events

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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

Publications:

Cleland JG, Coletta AP, Buga L, Ahmed D, Clark AL. Clinical trials update from the American College of Cardiology meeting 2010: DOSE, ASPIRE, CONNECT, STICH, STOP-AF, CABANA, RACE II, EVEREST II, ACCORD, and NAVIGATOR. Eur J Heart Fail. 2010 Jun;12(6):623-9. doi: 10.1093/eurjhf/hfq083.

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

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