Heart Failure Clinical Trial

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

Summary

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.
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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

203

Study ID:

NCT00729911

Recruitment Status:

Completed

Sponsor:

Texas Cardiac Arrhythmia Research Foundation

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There is 1 Location for this study

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Texas Cardiac Arrhythmia Research Foundation
Austin Texas, 78758, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 4

Estimated Enrollment:

203

Study ID:

NCT00729911

Recruitment Status:

Completed

Sponsor:


Texas Cardiac Arrhythmia Research Foundation

How clear is this clinincal trial information?

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