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

Primary Purpose

Atrial Fibrillation, Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rate Control
Ablation Therapy
Rate Control
Rate control
Rate control
Rate control
Rate Control
Rate Control
Rate Control
Rhythm Control
Rhythm control
Rhythm control
Rhythm control
Rhythm control
Rhythm control
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Left Atrial Ablation, Pulmonary Vein Isolation, Catheter Ablation, Antiarrhythmic Drug Therapy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have documented AF, which warrants active drug or ablative treatment
  • Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs
  • Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography

Exclusion Criteria:

  • Previously failed 2 or more membrane active anti-arrhythmic drugs
  • Efficacy failure of a full dose Amiodarone trial of >12 weeks duration
  • Any amiodarone therapy in the past three months
  • Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
  • Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age
  • Recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months
  • Hypertrophic obstructive cardiomyopathy
  • Class IV angina or congestive heart failure
  • Planned heart transplantation
  • Other mandated anti-arrhythmic drug therapy
  • Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class I or III drugs
  • Prior left atrial catheter ablation with the intention to treat AF
  • Patients with other arrhythmias requiring ablative therapy
  • Prior surgical interventions for AF such as the MAZE procedure
  • Prior atrioventricular nodal ablation
  • Medical conditions limiting expected survival to <1 year
  • Contraindication to warfarin anti-coagulation
  • Women of childbearing potential
  • Participation in any other clinical mortality trial
  • Unable to give informed consent

Sites / Locations

  • Universtity of Alabama Hospital
  • Good Samaritan Hospital
  • Loyola University
  • Mercy Medical Center
  • Johns Hopkins Hospital
  • Brigham and Womens Hospital
  • Mayo Clinic
  • Ohio State University Medical Center
  • University of Pennsylvania Health
  • Intermountain Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pharmacologic Therapy

Ablation Therapy

Arm Description

Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug.

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.

Outcomes

Primary Outcome Measures

Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Documentation of atrial fibrillation using a cardiac event recorder

Secondary Outcome Measures

Full Information

First Posted
December 14, 2007
Last Updated
December 3, 2012
Sponsor
Mayo Clinic
Collaborators
Duke Clinical Research Institute, Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00578617
Brief Title
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial
Acronym
CABANA
Official Title
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
Duke Clinical Research Institute, Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
Detailed Description
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Arrhythmia
Keywords
Atrial fibrillation, Left Atrial Ablation, Pulmonary Vein Isolation, Catheter Ablation, Antiarrhythmic Drug Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pharmacologic Therapy
Arm Type
Active Comparator
Arm Description
Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy. Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol. Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF. Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary. Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug.
Arm Title
Ablation Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rate Control
Other Intervention Name(s)
Toprol
Intervention Description
Metoprolol 50-100mg
Intervention Type
Device
Intervention Name(s)
Ablation Therapy
Other Intervention Name(s)
St. Jude: Livewire
Intervention Type
Drug
Intervention Name(s)
Rate Control
Other Intervention Name(s)
Tenormin
Intervention Description
Atenolol 50-100mg,
Intervention Type
Drug
Intervention Name(s)
Rate control
Other Intervention Name(s)
Inderal
Intervention Description
Propranolol 40-80mg
Intervention Type
Drug
Intervention Name(s)
Rate control
Other Intervention Name(s)
Sectral
Intervention Description
Acebutolol 200mg
Intervention Type
Drug
Intervention Name(s)
Rate control
Other Intervention Name(s)
Coreg
Intervention Description
Carvedilol 6.25mg
Intervention Type
Drug
Intervention Name(s)
Rate Control
Other Intervention Name(s)
Cardizem
Intervention Description
Diltiazem 180-240mg
Intervention Type
Drug
Intervention Name(s)
Rate Control
Other Intervention Name(s)
Calan
Intervention Description
Verapamil 180-240mg
Intervention Type
Drug
Intervention Name(s)
Rate Control
Other Intervention Name(s)
Lanoxin
Intervention Description
Digoxin 0.125mg
Intervention Type
Drug
Intervention Name(s)
Rhythm Control
Other Intervention Name(s)
Rhythmol
Intervention Description
Propafenone 450mg
Intervention Type
Drug
Intervention Name(s)
Rhythm control
Other Intervention Name(s)
Tambacor
Intervention Description
Flecainide 200mg
Intervention Type
Drug
Intervention Name(s)
Rhythm control
Other Intervention Name(s)
Betapace
Intervention Description
Sotalol 240mg
Intervention Type
Drug
Intervention Name(s)
Rhythm control
Other Intervention Name(s)
Tykosin
Intervention Description
Dofetilide 500mcg
Intervention Type
Drug
Intervention Name(s)
Rhythm control
Other Intervention Name(s)
Cordarone
Intervention Description
Amiodarone 200mg
Intervention Type
Drug
Intervention Name(s)
Rhythm control
Other Intervention Name(s)
Quini-glute/dex
Intervention Description
Quinidine 600-900mg
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Description
Documentation of atrial fibrillation using a cardiac event recorder
Time Frame
12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have documented AF, which warrants active drug or ablative treatment Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography Exclusion Criteria: Previously failed 2 or more membrane active anti-arrhythmic drugs Efficacy failure of a full dose Amiodarone trial of >12 weeks duration Any amiodarone therapy in the past three months Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age Recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months Hypertrophic obstructive cardiomyopathy Class IV angina or congestive heart failure Planned heart transplantation Other mandated anti-arrhythmic drug therapy Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class I or III drugs Prior left atrial catheter ablation with the intention to treat AF Patients with other arrhythmias requiring ablative therapy Prior surgical interventions for AF such as the MAZE procedure Prior atrioventricular nodal ablation Medical conditions limiting expected survival to <1 year Contraindication to warfarin anti-coagulation Women of childbearing potential Participation in any other clinical mortality trial Unable to give informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas L. Packer, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universtity of Alabama Hospital
City
Birminham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Loyola University
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60626
Country
United States
Facility Name
Mercy Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Pennsylvania Health
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20498271
Citation
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.
Results Reference
background
Links:
URL
http://clinicaltrials.mayo.edu
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial

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