Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

Texas Cardiac Arrhythmia Research Foundation

Status and phase: Completed; Phase 4

Conditions: Heart Failure

Treatments: Procedure: Atrial Fibrillation ablation; Drug: Amiodarone

Study type: Interventional

Funder types: Other

Identifiers

NCT00729911

AATAC-AF

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

AF ablation

Active Comparator group

Description:

Subjects assigned to the catheter ablation strategy will undergo catheter based AF ablation. The goal of the procedure is to achieve isolation of all 4 pulmonary veins. Subjects assigned to receive Amiodarone will have the oral medication initiated in an clinic setting.

Treatment:

Procedure: Atrial Fibrillation ablation

Amiodarone

Active Comparator group

Description:

Amiodarone is taken orally on a daily basis.

Treatment:

Drug: Amiodarone