Atrial Fibrillation, Arrhythmia
Conditions
Keywords
Atrial fibrillation, Left Atrial Ablation, Pulmonary Vein Isolation, Catheter Ablation, Antiarrhythmic Drug Therapy
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.
Interventions
DRUGRate Control
Metoprolol 50-100mg
DEVICEAblation Therapy
DRUGRate control
Propranolol 40-80mg
DRUGRhythm Control
Propafenone 450mg
DRUGRhythm control
Flecainide 200mg
Sponsors
Duke Clinical Research Institute
Abbott Medical Devices
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up | 12 months after intervention | Documentation of atrial fibrillation using a cardiac event recorder |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 31 |
| 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. | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Ablation Therapy | Drug Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 20 Participants | 38 Participants |
| Age Continuous | 60.3 years STANDARD_DEVIATION 11.46 | 62.1 years STANDARD_DEVIATION 9.57 | 61.2 years STANDARD_DEVIATION 10.47 |
| Region of Enrollment United States | 29 participants | 31 participants | 60 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 20 Participants | 26 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 31 | 10 / 29 |
| serious Total, serious adverse events | 4 / 31 | 12 / 29 |
Outcome results
Primary
Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Documentation of atrial fibrillation using a cardiac event recorder
Time frame: 12 months after intervention
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Drug Therapy | Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up | 20 participants |
| Ablation Therapy | Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up | 14 participants |