Heart Failure
Conditions
Keywords
Atrial fibrillation Ablation
Brief 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.
Interventions
PROCEDUREAtrial Fibrillation ablation
Radio-frequency catheter ablation of atrial fibrillation
DRUGAmiodarone
Taken orally on a daily basis.
Sponsors
Casa Sollievo della Sofferenza IRCCS
Catholic University, Italy
Southlake Regional Health Centre
Stanford University
University of Kansas
The University of Texas Medical Branch, Galveston
University of Foggia
Sutter Health
Texas Cardiac Arrhythmia Research Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Recurrence of AF lasting longer than 15 seconds | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Change in distance walked in 6-minute walk test | 1 year |
| Total number of hospitalizations during the trial period for each group | 1 year |
| Change in MLHF Quality of Life during trial period | 1 year |
| Change in EF during trial period | 1 year |
Countries
United States
Outcome results
None listed