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

Condition(s) targeted: Heart Failure

Intervention: Atrial Fibrillation ablation (Procedure); Amiodarone (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Texas Cardiac Arrhythmia Research Foundation

Official(s) and/or principal investigator(s):
Andrea Natale, MD, Principal Investigator, Affiliation: Texas Cardiac Arrhythmia Research Foundation

Overall contact:
Luigi Di Biase, Phone: 216-773-3879, Email: Luigi.Dibiase@stdavids.com

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.

Official title: Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: Time to Recurrence of AF lasting longer than 15 seconds

Secondary outcome:

Change in distance walked in 6-minute walk test

Total number of hospitalizations during the trial period for each group

Change in MLHF Quality of Life during trial period

Change in EF during trial period

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

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)

Luigi Di Biase, Phone: 216-773-3879, Email: Luigi.Dibiase@stdavids.com

Texas Cardiac Arrhythmia Research Foundation, Austin, Texas 78758, United States; Recruiting
Andrea Natale, Phone: 512-458-9410, Email: dscardinal@austinheartbeat.com

Starting date: October 2008
Ending date: August 2011
Last updated: October 8, 2009