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Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)

Primary Purpose

Atrial Fibrillation, Arrhythmia

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Left atrial ablation

Rate or Rhythm Control Therapy

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:

Over the preceding 6 months have:
1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) atrial fibrillation (AF) episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or
2. electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or
3. electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year).
Warrant active therapy (within the past 3 months) beyond simple ongoing observation
Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs.
Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a blood pressure >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, transient ischemic attack or systemic emboli, Atherosclerotic vascular disease (previous myocardial infarction (MI), peripheral arterial disease or aortic plaque), left atrial (LA) size >5.0 cm (or volume index ≥40 cc/m2), or ejection fraction (EF) ≤35.
Have the capacity to understand and sign an informed consent form.
Be ≥18 years of age.
- NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or left ventricular (LV) hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment.

Exclusion Criteria:

Lone AF in the absence of risk factors for stroke in patients <65 years of age
Patients who in the opinion of the managing clinician should not yet receive any therapy for AF
Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2)
An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time
Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
Recent cardiac events including MI, percutaneous intervention (PCI), or valve or bypass surgery in the preceding 3 months
Hypertrophic obstructive cardiomyopathy (outflow track)
Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation)
Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. ventricular tachycardia (VT), ventricular fibrillation (VF))
Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs
Prior LA catheter ablation with the intention of treating AF
Prior surgical interventions for AF such as the MAZE procedure
Prior AV nodal ablation
Patients with other arrhythmias requiring ablative therapy
Contraindication to appropriate anti-coagulation therapy
Renal failure requiring dialysis
Medical conditions limiting expected survival to <1 year
Women of childbearing potential (unless post-menopausal or surgically sterile)
Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center)
Unable to give informed consent
- NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.

Sites / Locations

Arkansas Cardiology, PA
Good Samaritan Hospital
University of California Los Angeles
University of California Davis Medical Center
University of California at San Francisco Medical Center
Stanford University Medical Center
The Medical Center of Aurora
Penrose Saint Francis Health Services
Hartford Hospital
George Washington University Medical Faculty Associates
University of Miami Hospital
Florida Hospital
Northside Hospital and Heart Institute
Tallahassee Memorial Hospital
Florida Heart Rhythm-University of South Florida College of Medicine
Georgia Regents University
Georgia Arrhythmia Consultants & Research Institute
Alexian Brothers Medical Center
Rush University Medical Center
NorthShore University Health System
Loyola University Medical Center
Mercy Medical Center-Iowa Heart Center
Johns Hopkins Hospital
Massachusetts General Hospital
Brigham and Womens Hospital
Henry Ford Hospital
Saint Joseph Mercy Hospital
Minneapolis V.A. Medical Center
Mayo Clinic Rochester
Park Nicollet Methodist Hospital
Jackson Heart Clinic
Saint John's Mercy Heart Health Center
Saint Louis Heart and Vascular
Cooper University Hospital
Hackensack University Medical Center
Robert Wood Johnson University Hospital
Albany Associates in Cardiology
Montefiore Medical Center
New York University Langone Medical Center
Columbia University Medical Center
Stony Brook University Hospital and Medical Center
University of North Carolina at Chapel Hill
The Sanger Clinic, PA
Duke University Medical Center
Wake Forest University Health Sciences
University of Cincinnati Medical Center
Cleveland Clinic Foundation
Ohio State University Medical Center
Oklahoma Heart Institute
Oregon Health and Science University
Providence Saint Vincent Medical Center
Geisinger Wyoming Valley Medical Center
Penn State University Cardiovascular Center
Drexel University College of Medicine
University of Pennsylvania Health System
V.A. Pittsburgh Healthcare System
Lankenau Hospital
Greenville Hospital System University Medical Center
Memorial Health Care System
Vanderbilt University Medical Center
Texas Cardiac Arrhythmia
Baylor Heart and Vascular Hospital
Baylor All Saints Medical Center
University of Texas Health Science Center
The Heart Hospital Baylor Plano
South Texas Cardiovascular Consultants
Scott and White Memorial Hospital
Intermountain Medical Center-LDS Hospital
University of Virginia Health System
Virginia Hospital Center - Arlington
Sentara Norfolk General Hospital
Virginia Commonwealth University Medical Center
Swedish Medical Center - Providence Campus
University of Washington Medical Center
Cardiac Study Center
Waukesha Memorial Hospital
Royal Adelaide Hospital
Royal Melbourne Hospital
University of Calgary
Hamilton Health Sciences
University of Western Ontario - London Health Sciences Centre
Southlake Regional Health Centre
Guangdong Provincial People's Hospital
First Affiliated Hospital of Nanjing Medical University
First Affiliated Hospital of Dalian Medical University
Beijing Anzhen Hospital
Fuwai Hospital
Na Homolce Hospital
Saint Anne's University Hospital, ICRC
Charles University
Clinic of Cardiology IKEM Medical Institute
University Hospital of Mannheim
Klinikum Coburg
Universitares Herrzentrum Hamburg
Herz-und Diabeteszentrum NRW
Technische Universitat Dresden
Kerckhoff Klinik
Praxisklinik Herz and GefaBe
CCB - Cardioaniologisches Centrum Bethanien
Georg-August-University
Asklepios Klinik St. Georg
Asklepios Klinik Barmbek
Saint Vincentius-Kliniken
Herzzentrum Leipzig
Universitat Rostock
Policlinico San Donato Center of Clinical Arrhythmia and Electrophysiology
Policlinico Multimedical Cardiology and Arrhythmia Centre
Ospedale di Circolo e Fondazione Macchi
Korea University Anam Hospital
Yonsei University Severance Hospital
Research Institute of Circulation of Pathology
Clinical Hospital # 83 under the Federal Medical and Biological Agency
Bakoulev Scientific Center for Cardiovascular Surgery
Scientific Research Institute of Cardiology of Ministry of Health of Russian Foundation
Golden Jubilee Hospital
Saint Bartholomew's Hospital
Saint George's Hospital Medical School
Saint Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Left Atrial Ablation

Rate or Rhythm Control Therapy

Arm Description

Pulmonary vein isolation using a circumferential ablative approach in the left atrium. Ablation may be performed using circular mapping catheter-guided ablation, antral isolation using a circular guided approach, or wide area circumferential ablation.

Current state-of-the-art drug therapy for atrial fibrillation (rate control or rhythm control). Treating physicians will be encouraged to follow the American College of Cardiology / American Heart Association / European Society of Cardiology Atrial Fibrillation Guidelines with regard to drug therapy for atrial fibrillation. The specific choice of rate control versus rhythm control drug therapy and the specific drugs to be used will ultimately be left to the discretion of the treating physician.

Outcomes

Primary Outcome Measures

Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.

All events for each component of the primary endpoint were reviewed and adjudicated in a blinded fashion by an independent clinical events committee using prospectively determined event definitions. Death was defined as all-cause mortality, disabling stroke (including intracranial bleeding) as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2, and serious bleeding as bleeding accompanied by hemodynamic compromise that required surgical intervention or a transfusion of ≥3 units of blood.

Secondary Outcome Measures

Number of Participants With All-cause Mortality

All deaths were reviewed and adjudicated by the Clinical Events Committee

Number of Participants With Mortality or Cardiovascular (CV) Hospitalization

Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.

Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events)

Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2 and the reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.

Number of Participants With Cardiovascular Death

Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator

Number of Participants With Cardiovascular Death or Disabling Stroke

Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2.

Number of Participants With an Arrhythmic Death or Cardiac Arrest

All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee

Number of Participants With Heart Failure Death

All deaths were categorized and adjudicated by the Clinical Events Committee

Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period

Data from patients using the study provided ECG event recording system were analyzed. A 30-second episode of AF in either group, confirmed through blinded review by an ECG Core Lab Committee was used for defining the endpoint of recurrent AF.

Number of Participants With Cardiovascular Hospitalization

The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.

Changes in Quality of Life Measures - AFEQT

Atrial Fibrillation Effect on Quality of Life (AFEQT) Overall Score (Scale: 0 = complete disability, 100 = no disability). The AFEQT is a 21-item AF-specific, health-related QOL questionnaire designed to assess the effect of atrial fibrillation on patient quality of life. The AFEQT has an Overall Score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. Overall and subscale scores range from 0 (corresponds to complete disability) to 100 (no AF-related disability).

Changes in Quality of Life Measures - MAFSI Frequency Score

The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI frequency of symptoms over the past month was recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), and 4 (always) for each of the 10 items listed in the questionnaire. The 10 item responses were summed for a total Frequency Score that ranged from 0 (no AF symptoms) to 40 (worst score).

Changes in Quality of Life Measures - MAFSI Severity Score

The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI severity scores over the past month were recorded as 1 (mild), 2 (moderate), and 3 (extreme) for each of the 10 items listed in the questionnaire. The 10 items items were then summed for the total Severity Score that ranged from 0 (no AF symptoms) to 30 (most severe AF symptoms).

Number of Participants With Adverse Events/Complications

Comparing individual non-endpoint adverse events between ablative and drug therapy is difficult due to the substantial difference in the types of adverse events expected. Ablation-related events were counted among all patients that were randomized to and received an ablation. Drug-related events were counted among all patients that were randomized to and received drug therapy.

Full Information

NCT ID

NCT00911508

First Posted

May 28, 2009

Last Updated

April 19, 2021

Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Abbott Medical Devices, Biosense Webster, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00911508

Brief Title

Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Acronym

CABANA

Official Title

Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

November 13, 2009 (Actual)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

Collaborators

National Heart, Lung, and Blood Institute (NHLBI), Abbott Medical Devices, Biosense Webster, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The (Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial) CABANA Trial has the overall goal of establishing the appropriate roles for medical and ablative intervention for atrial fibrillation (AF). The CABANA Trial is designed to test the hypothesis that the treatment strategy of left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) will be superior to current state-of-the-art therapy with either rate control or rhythm control drugs for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients with untreated or incompletely treated AF.

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. This study will randomize up to 2200 patients to a strategy of catheter ablation versus pharmacologic therapy with rate or rhythm control drugs. Each pt will have 1) characteristics similar to AFFIRM pts (≥65 yo or <65 with >1 risk factor for stroke, 2) Documented AF warranting treatment, and 3) Eligibility for both catheter ablation and ≥2 anti-arrhythmic or ≥2 rate control drugs. Pts will be followed every 6 months for an average of approximately 5 years and will undergo repeat trans-telephonic monitor, Holter monitor, and CT/MR studies to assess the impact of treatment. The CABANA trial will disclose the role of medical and non-pharmacologic therapies for AF, establish the cost and impact of therapy on quality of life and will help determine if AF is a modifiable risk factor for increased mortality.

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

2204 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Left Atrial Ablation

Arm Type

Active Comparator

Arm Description

Arm Title

Rate or Rhythm Control Therapy

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Left atrial ablation

Intervention Description

St. Jude: Livewire TC™ , Therapy™ Dual / Thermocouple, Safire,Therapy Cool Path Biosense Webster: NAVI-STAR, NAVI-STAR/NAVI-STAR DS, Celsius Braided/Long Tip, NAVI-STAR™ and Celsius™ ThermoCool, NAVI-STAR® RMT, Celsius® RMT, ThermoCool® SF Medtronic CryoCath LP: Freezor®/Freezor MAX®, Artic Front®, Cardiac Ablation System Bard: Stinger Boston Scientific: Blazer II RF/XP, Blazer RPM, Chilli II Cooled, SteeroCath

Intervention Type

Drug

Intervention Name(s)

Rate or Rhythm Control Therapy

Intervention Description

Rate control: Metoprolol 50-100mg, Atenolol 50-100mg, Propranolol 40-80mg, Acebutolol 200-300mg, Carvedilol 6.25-25mg, Diltiazem 180-240mg, Verapamil 180-240mg, Digoxin 0.125-0.25mg Rhythm control: Propafenone 450-625mg, Flecainide 200-300mg, Sotalol 240-320mg, Dofetilide 500-1000mcg, Amiodarone 200-400mg, Quinidine 600-900mg, Dronedarone 800mg

Primary Outcome Measure Information:

Title

Number of Participants With Composite of Total Mortality, Disabling Stroke, Serious Bleeding, or Cardiac Arrest in Patients Warranting Therapy for AF.

Description

Time Frame

From date of enrollment until time-to-first event over a median follow-up of 48.5 months.

Secondary Outcome Measure Information:

Title

Number of Participants With All-cause Mortality

Description

All deaths were reviewed and adjudicated by the Clinical Events Committee

Time Frame

From date of enrollment until date of death over a median follow-up of 48.5 months.

Title

Number of Participants With Mortality or Cardiovascular (CV) Hospitalization

Description

Hospitalization was characterized by the site principal investigator (PI) and reported as part of the hospitalization case report form.

Time Frame

From date of enrollment until time-to-first event of death or CV hospitalization over a median follow-up of 48.5 months.

Title

Number of Participants With Mortality, Disabling Stroke, or CV Hospitalization (for Heart Failure or Acute Ischemic Events)

Description

Time Frame

From date of enrollment until time-to-first event of death, stroke, or CV hospitalization (for heart failure or acute ischemic event) over a median follow-up of 48.5 months.

Title

Number of Participants With Cardiovascular Death

Description

Cardiovascular death as determined by the Clinical Events Committee based on the available data provided by the Principal Investigator

Time Frame

From date of enrollment until date of a cardiovascular death over a median follow-up of 48.5 months.

Title

Number of Participants With Cardiovascular Death or Disabling Stroke

Description

Disabling stroke (including intracranial bleeding) was defined as an irreversible physical limitation defined by a Rankin Stroke Scale ≥2.

Time Frame

From date of enrollment until time-to-first event of a cardiovascular death or disabling stroke over a median follow-up of 48.5 months.

Title

Number of Participants With an Arrhythmic Death or Cardiac Arrest

Description

All deaths and cardiac arrest events were adjudicated by the Clinical Events Committee

Time Frame

From date of enrollment until time-to-first event for an arrhythmic death or cardiac arrest over a median follow-up of 48.5 months.

Title

Number of Participants With Heart Failure Death

Description

All deaths were categorized and adjudicated by the Clinical Events Committee

Time Frame

From date of enrollment until date of heart failure death over a median follow-up of 48.5 months.

Title

Number of Participants Free From Recurrent Atrial Fibrillation (AF) Following the 90 Day Blanking Period

Description

Time Frame

From date of therapy initiation until date of first AF recurrence following a 90 day wait (blanking) period over a median follow-up of 48.5 months.

Title

Number of Participants With Cardiovascular Hospitalization

Description

The reason for hospitalization was characterized by the site PI and reported as part of the hospitalization case report form.

Time Frame

From date of enrollment until date of cardiovascular hospitalization over a median follow-up of 48.5 months.

Title

Changes in Quality of Life Measures - AFEQT

Description

Time Frame

Baseline ,12 month, 5 years

Title

Changes in Quality of Life Measures - MAFSI Frequency Score

Description

Time Frame

Baseline, 12 Month, 5 Year

Title

Changes in Quality of Life Measures - MAFSI Severity Score

Description

The Mayo AF-Specific Symptom Inventory (MAFSI) is a questionnaire comprised of a 10-item AF symptom checklist that asked about both the frequency and severity of each symptom. MAFSI severity scores over the past month were recorded as 1 (mild), 2 (moderate), and 3 (extreme) for each of the 10 items listed in the questionnaire. The 10 items items were then summed for the total Severity Score that ranged from 0 (no AF symptoms) to 30 (most severe AF symptoms).

Time Frame

Baseline, 12 Month, 5 Year

Title

Number of Participants With Adverse Events/Complications

Description

Time Frame

From treatment start date to date of event over a median follow-up of 48.5 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Over the preceding 6 months have: ≥2 paroxysmal (electrocardiographic documentation of at least 1) atrial fibrillation (AF) episodes lasting ≥1 hour in duration: (that terminate spontaneously within 7 days or cardioversion is performed within 48h of AF onset): or electrocardiographic documentation of 1 persistent AF episode: (sustained for ≥7 days or cardioversion is performed more than 48h after AF onset): or electrocardiographic documentation of 1 longstanding persistent AF episode: (continuous AF of duration >1 year). Warrant active therapy (within the past 3 months) beyond simple ongoing observation Be eligible for catheter ablation and ≥2 sequential rhythm control and/or ≥2 rate control drugs. Be ≥65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension (treated and/or defined as a blood pressure >140/90 mmHg) [90], Diabetes (treated and/or defined as a fasting glucose ≥126 mg/dl) [91], Congestive heart failure (including systolic or diastolic heart failure), Prior stroke, transient ischemic attack or systemic emboli, Atherosclerotic vascular disease (previous myocardial infarction (MI), peripheral arterial disease or aortic plaque), left atrial (LA) size >5.0 cm (or volume index ≥40 cc/m2), or ejection fraction (EF) ≤35. Have the capacity to understand and sign an informed consent form. Be ≥18 years of age. NOTE- Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or left ventricular (LV) hypertrophy to qualify.Patients receiving new drug therapy initiated within the previous 3 months may continue that therapy if randomized to the drug therapy arm. Patients may have documented atrial flutter in addition to atrial fibrillation and remain eligible for enrollment. Exclusion Criteria: Lone AF in the absence of risk factors for stroke in patients <65 years of age Patients who in the opinion of the managing clinician should not yet receive any therapy for AF Patients who have failed >2 membrane active anti-arrhythmic drugs at a therapeutic dose due to inefficacy or side effects (Table 5.2.2) An efficacy failure of full dose amiodarone treatment >8 weeks duration at any time Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma Recent cardiac events including MI, percutaneous intervention (PCI), or valve or bypass surgery in the preceding 3 months Hypertrophic obstructive cardiomyopathy (outflow track) Class IV angina or Class IV congestive heart failure (CHF) (including past or planned heart transplantation) Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. ventricular tachycardia (VT), ventricular fibrillation (VF)) Heritable arrhythmias or increased risk for torsade de pointes with class I or III drugs Prior LA catheter ablation with the intention of treating AF Prior surgical interventions for AF such as the MAZE procedure Prior AV nodal ablation Patients with other arrhythmias requiring ablative therapy Contraindication to appropriate anti-coagulation therapy Renal failure requiring dialysis Medical conditions limiting expected survival to <1 year Women of childbearing potential (unless post-menopausal or surgically sterile) Participation in any other clinical mortality trial (Participation in other non-mortality trials should be reviewed with the clinical trial management center) Unable to give informed consent NOTE- Prior ablation of the cavo-tricuspid isthmus alone is not an exclusion if the patient develops subsequent recurrent AF. Planned atrial flutter ablation in combination with the left atrial ablation is not an exclusion.

Overall Study Officials: