Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Atrial Fibrillation, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/26/2018 |
| Start Date: | October 2008 |
| End Date: | December 2018 |
Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD
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.
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)
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