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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Collaborators: Casa Sollievo della Sofferenza IRCCS; Catholic University, Italy; Southlake Regional Health Centre; Stanford University; Sutter Health; The University of Texas Medical Branch, Galveston; University of Foggia; University of Kansas
• Treatments: Amiodarone

Criteria

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)