Trial record 1 of 1 for:    NCT00911508
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Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial (CABANA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mayo Clinic
Sponsor:
Collaborators:
St. Jude Medical
Biosense Webster, Inc.
Information provided by (Responsible Party):
Douglas L. Packer, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00911508
First received: May 28, 2009
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Atrial Fibrillation
Arrhythmia
Device: Left atrial ablation
Drug: Rate or Rhythm Control Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • LA catheter ablation is superior to rate or rhythm control drug therapy for decreasing the incidence of the composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest in patients warranting therapy for AF. [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LA catheter ablation is superior to rate or rhythm control drug therapy for reducing total mortality [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Total mortality or cardiovascular hospitalization [ Time Frame: From date of enrollment until date of death or CV hospitalization ] [ Designated as safety issue: Yes ]
  • Cardiovascular death [ Time Frame: From date of enrollment until date of death ] [ Designated as safety issue: Yes ]
  • Cardiovascular death or disabling stroke [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Arrhythmic death or cardiac arrest [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Heart failure death [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Freedom from recurrent AF [ Time Frame: From date of therapy initiation until date of first AF recurrence following a 90 day wait period ] [ Designated as safety issue: No ]
  • Cardiovascular hospitalization [ Time Frame: From date of enrollment until date of hospitalization ] [ Designated as safety issue: Yes ]
  • Medical costs, resource utilization, and cost effectiveness [ Time Frame: From date of enrollment through follow-up (average of 5 years) ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: At months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 ] [ Designated as safety issue: No ]
  • Composite adverse events [ Time Frame: From date of enrollment until date of event ] [ Designated as safety issue: Yes ]
  • Left atrial size, morphology and function and its relationship to morbidity and mortality [ Time Frame: Baseline compared with 3-6 months post therapy initiation ] [ Designated as safety issue: No ]

Estimated Enrollment: 2200
Study Start Date: August 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Left Atrial Ablation
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.
Device: Left atrial ablation

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

Active Comparator: Rate or Rhythm Control Therapy
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.
Drug: Rate or Rhythm Control Therapy

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


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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Over the preceding 6 months have:

    1. ≥2 paroxysmal (electrocardiographic documentation of at least 1) 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 BP >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, TIA or systemic emboli, Atherosclerotic vascular disease (previous MI, peripheral arterial disease or aortic plaque), LA size >5.0 cm (or volume index ≥40 cc/m2), or 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 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, PCI, or valve or bypass surgery in the preceding 3 months
  • Hypertrophic obstructive cardiomyopathy (outflow track)
  • Class IV angina or Class IV CHF (including past or planned heart transplantation)
  • Other arrhythmias mandating anti-arrhythmic drug therapy (i.e. VT, 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911508

Contacts
Contact: Kristi H. Monahan, RN, BS 507-255-6676 CABANA@mayo.edu
Contact: Mona Branstad 507-538-4358 CABANA@mayo.edu

  Show 134 Study Locations
Sponsors and Collaborators
Mayo Clinic
St. Jude Medical
Biosense Webster, Inc.
Investigators
Principal Investigator: Douglas L. Packer, M.D. Mayo Clinic
Principal Investigator: Kerry L. Lee, Ph.D. Duke Clinical Research Institute
Principal Investigator: Daniel B. Mark, M.D., MPH Duke Clinical Research Institute
Principal Investigator: Rich A. Robb, Ph.D. Phy Mayo Clinic
Study Chair: Yves D. Rosenberg, M.D., MPH National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
No publications provided

Responsible Party: Douglas L. Packer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00911508     History of Changes
Other Study ID Numbers: 08-007043 09-004616, U01HL089709
Study First Received: May 28, 2009
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government

Keywords provided by Mayo Clinic:
Atrial Fibrillation
Left Atrial Ablation
Pulmonary Vein Isolation
Catheter Ablation
Antiarrhythmic Drug Therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014