Clinical Trials

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

Location:

Rochester,  MN

Trial status:

Open for Enrollment

Why is this study being done?

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 3000 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 ≥3 rate control drugs. Pts will be followed every 6 months for >2 yrs 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.

Who is eligible to participate?

Inclusion Criteria:

- Have the capacity to understand and sign an informed consent form

- Be ≥18 years of age.

- Have documented AF episodes ≥1 hour in duration; with ≥2 episodes over 4 months with electrocardiographic documentation of 1 episode or at least 1 episode of AF lasting more than 1 week

- Warrant active therapy beyond simple ongoing observation

- Be eligible for both catheter ablation and ≥2 sequential rhythm control and/or ≥3 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, Prior stroke or TIA, LA size ≥5.0 cm (or volume index ≥40 cc/m2), or EF ≥35. Subjects <65 yrs of age whose only risk factor is hypertension must have a second risk factor or LV hypertrophy to qualify.

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

- More than one week of amiodarone treatment in the past 3 months

- An efficacy failure of full dose amiodarone treatment ≥12 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

- Class IV angina or Class IV CHF (including past or planned heart transplantation)

- Other mandated anti-arrhythmic drug therapy

- 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 warfarin anti-coagulation

- 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

- Unable to give informed consent

Last updated: 03/05/2013

NCT ID:

NCT00911508