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

Completed · Phase 4

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT00729911

Run by

Texas Cardiac Arrhythmia Research Foundation

People needed

203

Starts

2008-10-01

Expected to finish

2015-12-01

Last updated by the study team

2019-04-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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,
• 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.
• Therapeutic anticoagulation for at least three weeks prior to initiation of therapy
• Ability to complete 6 minute walk test.
• 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).
• All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker.
• patients receiving low dose amiodarone- <200 mg for 2 or less months

You may not qualify if…

• The exclusion criteria are:
• Reversible causes of AF such as pericarditis, hyperthyroidism,
• Presently with Valvular Heart disease requiring surgical intervention
• Presently with coronary artery disease requiring surgical intervention
• Early Post-operative AF (within three months of surgery)
• Previous MAZE or left atrial instrumentation
• Prolonged QT interval
• Hypothyroidism
• Liver Failure
• Life expectancy <= 2 years
• Social factors that would preclude follow up or make compliance difficult.
• Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin
• Enrollment in another investigational drug or device study.
• Patients with severe pulmonary disease i.e. COPD or asthma
• Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction
• Any ophthalmologic disorders (other than requiring glasses for vision correction)

Where it is running

• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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