Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
1. To determine if catheter-based atrial fibrillation (AF) ablation is superior to
 Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with
 an impaired left ventricular function.

 2. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic
 persistent or permanent AF and impaired LV function in terms of recurrence of AF,
 quality of life, 6-minute walk distance, EF and total number of hospitalizations.
Inclusion Criteria:

 1. Patients with an dual chamber ICD or CRTD (with an existing functional atrial lead)
 with remote monitoring capabilities and EF <= 40% within the last 3 months by
 echocardiogram, nuclear imaging, MRI or cardiac catheterization,

 2. Persistent or chronic symptomatic AF resistant to anti-arrhythmic medication other
 than Amiodarone. Resistant defined as recurrent AF of greater than 5 minutes duration
 at least once per month.

 3. Therapeutic anticoagulation for at least three weeks prior to initiation of therapy

 4. Ability to complete 6 minute walk test.

 5. Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a
 protocol-acceptable method of birth control [defined as injectable or implantable
 hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus
 spermicide], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation
 performed at least 6 months prior to enrollment).

 6. All patients optimized on CHF medications including beta-blocker and ace-inhibitor or
 angiotensin-receptor blocker.

 7. patients receiving low dose amiodarone- <200 mg for 2 or less months

 Exclusion Criteria:

 The exclusion criteria are:

 1. Reversible causes of AF such as pericarditis, hyperthyroidism,

 2. Presently with Valvular Heart disease requiring surgical intervention

 3. Presently with coronary artery disease requiring surgical intervention

 4. Early Post-operative AF (within three months of surgery)

 5. Previous MAZE or left atrial instrumentation

 6. Prolonged QT interval

 7. Hypothyroidism

 8. Liver Failure

 9. Life expectancy <= 2 years

 10. Social factors that would preclude follow up or make compliance difficult.

 11. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin

 12. Enrollment in another investigational drug or device study.

 13. Patients with severe pulmonary disease i.e. COPD or asthma

 14. Documented intra-atrial thrombus, tumor, or another abnormality which precludes
 catheter introduction

 15. Any ophthalmologic disorders (other than requiring glasses for vision correction)